Implantable Cardioverter Defibrillator (Non-Crt)

FDA product classification. Device class 3. Review panel CV.

Classification

Each row is one field of the openFDA record. The grey name is the field’s name in openFDA’s documentation.

Field	Value	Field name
Product code	LWS	product_code
Device name	Implantable Cardioverter Defibrillator (Non-Crt)	device_name
Device class	3	device_class
Review panel	CV	review_panel
Regulation number	empty	regulation_number
Medical specialty	Unknown	medical_specialty

Source: FDA openFDA, device/classification, product code LWS, as held in ArrHub’s controlled vocabulary with its citation. Public domain (CC0).

PMA records with this code

Every verified record ArrHub holds under the code, newest first.

Decision	Applicant	Device	Record
2026-08-25	Boston Scientific	Tachy Pulse Generators	P960040/S515 FDA
2026-08-12	ABBOTT MEDICAL	Avant (CDVRA700Q, CDDRA700Q, CDVRA700T, CDDRA700T); Neutrino NxT (CDVRA800Q, CDVRA600Q, CDDRA800Q, CDDRA600Q, CDVRA600T, (truncated in the FDA record)	P910023/S487 FDA
2026-07-31	Medtronic Cardiac Rhythm Disease Management	Evera MRI DF-1 ICD (DDMB1D1, DDMC3D1, DVMB1D1, DVMC3D1); Evera MRI ICD (DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4); Evera S DR (truncated in the FDA record)	P980016/S963 FDA
2026-07-31	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I (truncated in the FDA record)	P980016/S962 FDA
2026-07-31	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I (truncated in the FDA record)	P980016/S961 FDA
2026-07-31	Medtronic, Inc.	Aurora EV-ICD (DVEA3E4)	P220012/S075 FDA
2026-07-31	Medtronic, Inc.	Aurora EV ICD (DVEA3E4)	P220012/S074 FDA
2026-07-23	Boston Scientific	ICD INOGEN™ VR DF4 (D010); ICD INOGEN™ VR DF1/IS1 (D011); ICD INOGEN™ DR DF4/IS1 (D012); ICD INOGEN™ DR DF1/IS1 (D013); (truncated in the FDA record)	P960040/S516 FDA
2026-07-23	Boston Scientific Corporation	S-ICD EMBLEM™ GEN 2 (A209); S-ICD EMBLEM™ MRI (A219)	P110042/S215 FDA
2026-07-22	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D (truncated in the FDA record)	P980016/S960 FDA
2026-07-21	ABBOTT MEDICAL	Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs	P910023/S482 FDA
2026-07-16	Medtronic Cardiac Rhythm Disease Management	Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI DR ICD, Primo MRI VR ICD, (truncated in the FDA record)	P980016/S959 FDA
2026-07-16	Medtronic, Inc.	Aurora EV ICD	P220012/S073 FDA
2026-07-09	ABBOTT MEDICAL	Avant (CDVRA700Q, CDVRA700T); Neutrino NxT (CDVRA800Q, CDVRA800T, CDVRA600Q, CDVRA600T); Gallant (CDVRA500Q, CDVRA500T); (truncated in the FDA record)	P910023/S486 FDA
2026-07-07	Boston Scientific Corporation	EMBLEM™ S-ICD Electrode (Lead) Model 3501	P110042/S210 FDA
2026-07-01	Biotronik, Inc.	Plexa ProMRI S 60, Plexa ProMRI S 65, Plexa ProMRI S 75, Plexa ProMRI SD 60/16, Plexa ProMRI SD 65/16, Plexa ProMRI SD 6 (truncated in the FDA record)	P980023/S148 FDA
2026-07-01	Boston Scientific	TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA	P960040/S513 FDA
2026-07-01	Boston Scientific	LATITUDE™ NXT Remote Patient Management System; LATITUDE™ NXT System Server Software Model 6460	P910077/S198 FDA
2026-07-01	Boston Scientific Corporation	Emblem S-ICD (A209); Emblem MRI S-ICD (A219)	P110042/S214 FDA
2026-07-01	Boston Scientific Corporation	EMBLEM S-ICD	P110042/S211 FDA
2026-06-26	ABBOTT MEDICAL	Durata Leads; Optisure Leads; UltiSync Leads	P950022/S154 FDA
2026-06-25	Medtronic Cardiac Rhythm Disease Management	Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4 Evera S DR ICD DDBC3D4 Evera S VR ICD DVBC3D4 Evera XT VR ICD DVBB1D4 M (truncated in the FDA record)	P980016/S955 FDA
2026-06-25	Medtronic, Inc.	Aurora EV ICD DVEA3E4	P220012/S069 FDA
2026-06-24	Biotronik, Inc.	Acticor Sky VR-T (481989); Rivacor Sky VR-T (481984); Rivacor Rise VR-T (482020); Rivacor Aura VR-T (482015); Acticor Sk (truncated in the FDA record)	P980023/S147 FDA
2026-06-09	Boston Scientific	RELIANCE™ S Passive Single Coil, RELIANCE S Active Fix Single Coil, RELIANCE Passive Dual Coil, RELIANCE Active Fix Dual (truncated in the FDA record)	P910073/S192 FDA
2026-06-03	Boston Scientific	INOGEN, DYNAGEN, MOMENTUM, VIGILANT EL, PERCIVA MINI, RESONATE EL, PERCIVA HF, RESONATE HF	P960040/S514 FDA
2026-06-03	Boston Scientific	Endotak Reliance Leads (0128, 0137, 0138, 0147, 0148, 0157, 0158); Endotak Reliance 4-Site Leads (0262, 0263, 0265, 0266 (truncated in the FDA record)	P910073/S191 FDA
2026-06-03	Boston Scientific Corporation	S-ICD Electrode Model: 3501	P110042/S213 FDA
2026-06-03	Boston Scientific Corporation	EMBLEM, EMBLEM MRI	P110042/S212 FDA
2026-05-15	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I (truncated in the FDA record)	P980016/S958 FDA
2026-05-15	Boston Scientific	Hex Wrench (#2) (Model 6501)	P930035/S037 FDA
2026-05-15	Boston Scientific	DF-1 Plug (Model 6996)	P910077/S199 FDA
2026-05-15	Boston Scientific	ACUITY™ X4 Connector Tool (Model 4625); RELIANCE™ 4-FRONT Suture Sleeve (aka Lead Stabilizer) (Model 6403); Lead Cap Kit (truncated in the FDA record)	P910073/S190 FDA
2026-05-15	Boston Scientific	Vein Pick (Model 6541)	P830060/S093 FDA
2026-05-07	Biotronik, Inc.	Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, Rivacor Aura VR-T, Acticor Sky VR-T DX, Rivacor Sky VR-T DX, Riva (truncated in the FDA record)	P980023/S145 FDA
2026-04-30	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Eve (truncated in the FDA record)	P980016/S957 FDA
2026-04-30	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2DL DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI IC (truncated in the FDA record)	P980016/S951 FDA
2026-04-30	Medtronic, Inc.	Aurora EV-ICD	P220012/S072 FDA
2026-04-28	Medtronic Cardiac Rhythm Disease Management	Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI DR ICD, Primo MRI VR ICD, (truncated in the FDA record)	P980016/S956 FDA
2026-04-28	Medtronic, Inc.	Aurora EV ICD, Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD	P220012/S071 FDA
2026-04-24	ABBOTT MEDICAL	Durata Leads (7120, 7121, 7122, 7120Q, 7121Q, 7122Q, 7170, 7170Q, 7172Q, 7171Q)	P950022/S152 FDA
2026-04-24	ABBOTT MEDICAL	Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs	P910023/S484 FDA
2026-04-22	Boston Scientific	RELIANCE S Active Fix Single Coil IS-1/DF-1 59cm (Model 0137); RELIANCE S Active Fix Single Coil IS-1/DF-1 64cm (Model 0 (truncated in the FDA record)	P910073/S189 FDA
2026-04-21	Boston Scientific	Implantable Cardioverter Defibrillators (ICD) RESONATE: D420, D421, D432, D433, D520, D521, D532, D533; MOMENTUM: D120, (truncated in the FDA record)	P960040/S507 FDA
2026-04-15	Medtronic, Inc.	Transvene CS/SVC Lead (6937A)	P980050/S146 FDA
2026-04-15	Medtronic Cardiac Rhythm Disease Management	End Cap (6701), Sizing Sleeve (6920), Upsizing Sleeve (6925)	P900061/S176 FDA
2026-04-15	Medtronic, Inc.	Epsila EV Extravascular Lead	P220012/S070 FDA
2026-04-10	Boston Scientific	Wrench Kit Model 6501	P930035/S036 FDA
2026-04-10	Boston Scientific	Lead Port Plug Model 6996	P910077/S197 FDA
2026-04-10	Boston Scientific	• ACUITY X4 Connector Tool Model 4625 • AICD Lead Stylets Firm Model 6971 • AICD Lead Stylets Soft Model 6972 • Suture S (truncated in the FDA record)	P910073/S188 FDA
2026-04-10	Boston Scientific	Vein Pick Model 6541	P830060/S092 FDA
2026-04-01	Boston Scientific	VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (truncated in the FDA record)	P960040/S512 FDA
2026-03-27	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD	P980016/S954 FDA
2026-03-27	ABBOTT MEDICAL	Avant (CDVRA700Q, CDDRA700Q, CDVRA700T, CDDRA700T); Neutrino NxT (CDVRA800Q, CDVRA600Q CDDRA800Q, CDDRA600Q CDVRA600T, C (truncated in the FDA record)	P910023/S485 FDA
2026-03-06	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR I CD; Ev (truncated in the FDA record)	P980016/S953 FDA
2026-03-06	Boston Scientific	ENDOTAK RELIANCE™ / RELIANCE 4-FRONT™ pace/sense defibrillation leads	P910073/S187 FDA
2026-03-06	Medtronic, Inc.	Aurora EV ICD; Epsila EV Extravascular Lead	P220012/S068 FDA
2026-03-05	Biotronik, Inc.	Acticor Sky VR-T (481989); Rivacor Sky VR-T (481984); Rivacor Rise VR-T (482020); Rivacor Aura VR-T (482015); Acticor Sk (truncated in the FDA record)	P980023/S144 FDA
2026-03-04	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI ICD (DDPB3Dl, DDPB3D4, DVPB3Dl, DVPB3D4); Cobalt XT MRI ICD (DDPA2Dl, DDPA2D4, DVPA2Dl, DVPA2D4); Crome MRI I (truncated in the FDA record)	P980016/S952 FDA
2026-02-20	Boston Scientific	ENDOTAK RELIANCE™ / RELIANCE 4-FRONT™ pace/sense defibrillation leads	P910073/S185 FDA
2026-02-20	Boston Scientific Corporation	EMBLEM S-ICD Electrode (Lead)	P110042/S203 FDA
2026-02-19	ABBOTT MEDICAL	Durata, Optisure	P950022/S148 FDA
2026-02-13	Boston Scientific	RELIANCE 4-FRONT™/model 0636; RELIANCE 4-FRONT/ model 0662; RELIANCE 4-FRONT/ model 0663 00802526592805 P910073; RELIANC (truncated in the FDA record)	P910073/S186 FDA
2026-02-13	ABBOTT MEDICAL	Avant (CDVRA700Q, CDVRA700T); Neutrino NxT (CDVRA800Q, CDVRA800T, CDVRA600Q, CDVRA600T); Gallant (CDVRA500Q, CDVRA500T); (truncated in the FDA record)	P910023/S483 FDA
2026-02-13	Boston Scientific Corporation	EMBLEM™ S-ICD/ model 3501	P110042/S208 FDA
2026-02-12	Medtronic Cardiac Rhythm Disease Management	Evera MRI DF-1 ICD DDMB1D1, DDMC3D1, DVMB1D1, DVMC3D1 Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4 Evera S DR ICD DD (truncated in the FDA record)	P980016/S949 FDA
2026-02-12	Medtronic, Inc.	Aurora EV ICD DVEA3E4	P220012/S067 FDA
2026-02-11	Biotronik, Inc.	PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM	P980023/S142 FDA
2026-02-11	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Evera XT VR ICD; Mirro (truncated in the FDA record)	P980016/S947 FDA
2026-02-11	Medtronic, Inc.	Aurora EV ICD	P220012/S065 FDA
2026-02-10	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I (truncated in the FDA record)	P980016/S948 FDA
2026-02-10	Medtronic, Inc.	Aurora EV ICD DVEA3E4	P220012/S066 FDA
2026-02-03	Biotronik, Inc.	PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM	P980023/S143 FDA
2026-01-23	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Eve (truncated in the FDA record)	P980016/S945 FDA
2026-01-23	Medtronic, Inc.	Aurora EV-ICD System	P220012/S064 FDA
2026-01-16	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD	P980016/S946 FDA
2026-01-08	Boston Scientific	NG3 Implantable Cardioverter Defibrillators (ICDs): DYNAGEN Models: D020, D021, D022, D023, D150, D151, D152, D153; INOG (truncated in the FDA record)	P960040/S505 FDA
2026-01-08	Boston Scientific Corporation	Subcutaneous Implantable Cardioverter Defibrillator (S-ICD): EMBLEM S-ICD Model A209 and EMBLEM MRI S-ICD Model A219	P110042/S204 FDA
2026-01-05	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4 Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4 Crome MRI ICD DDP (truncated in the FDA record)	P980016/S944 FDA
2026-01-05	Medtronic, Inc.	Aurora EV ICD DVEA3E4	P220012/S063 FDA
2023-10-20	Medtronic, Inc.	Aurora EV-ICD System	P220012 FDA
2012-09-28	Boston Scientific Corporation	SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM	P110042 FDA
2000-06-14	Medtronic, Inc.	MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOF (truncated in the FDA record)	P980050 FDA
1998-10-27	Biotronik, Inc.	PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM	P980023 FDA
1998-10-09	Medtronic Cardiac Rhythm Disease Management	VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS	P980016 FDA
1997-07-18	Boston Scientific	VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (truncated in the FDA record)	P960040 FDA
1996-05-10	ABBOTT MEDICAL	TVL(TM) LEAD SYSTEM	P950022 FDA
1995-03-10	Boston Scientific	VENTAK(R) P2 SYSTEM	P930035 FDA
1994-06-17	Boston Scientific	VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR	P910077 FDA
1993-08-26	Boston Scientific	ENDOTAK LEAD SYSTEM	P910073 FDA
1993-04-30	ABBOTT MEDICAL	CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM	P910023 FDA
1993-02-11	Medtronic Cardiac Rhythm Disease Management	MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM	P900061 FDA
1985-10-04	Boston Scientific	VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS	P830060 FDA

510(k) clearances with this code

Every verified record ArrHub holds under the code, newest first.

None in the verified view.

ArrHub

What ArrHub adds to the record. Everything above this line is the agency’s; everything here is ArrHub’s, dated and attributed.

ArrHub vocabulary

Electrophysiology

LWS is one of the 56 product codes in ArrHub’s electrophysiology vocabulary, each held with its FDA classification record as its citation. Vocabulary entry verified 20 September 2026.

Raw record

The stored record exactly as ArrHub holds it, for anyone who wants to check the page against it.

Show the raw record (JSON)device/classification.json?search=product_code:LWS

{
  "id": "fda_product_code:LWS",
  "vocabulary": "fda_product_code",
  "term": "LWS",
  "definition": "Implantable Cardioverter Defibrillator (Non-Crt)",
  "attrs": {
    "device_class": "3",
    "review_panel": "CV",
    "medical_specialty": "Unknown",
    "regulation_number": ""
  },
  "jurisdiction": "US",
  "authority": "FDA",
  "ep_relevant": true,
  "source_url": "https://api.fda.gov/device/classification.json?search=product_code:LWS",
  "verified_by": "Bruno Deslauriers",
  "verified_at": "2026-09-20T01:22:27.524165+00:00",
  "notes": "Fetched from https://open.fda.gov/apis/device/classification/",
  "created_at": "2026-09-20T01:09:15.221345+00:00",
  "updated_at": "2026-09-20T01:19:10.492+00:00"
}

The readable page is rendered from the record held in ArrHub’s verified view; the agency record at api.fda.gov governs where they differ.

Links open the agency’s own records. Unlabelled links open web pages. Links marked (JSON) open an agency’s data record, which a browser shows as plain text.

Report a broken link or a record that does not match its source: alerts@arrhub.com. Corrections are published, with their date, at arrhub.com/corrections.