Implantable Pulse Generator, Pacemaker (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	LWP	product_code
Device name	Implantable Pulse Generator, Pacemaker (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 LWP, 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
2026-07-31	Medtronic, Inc.	Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena Quadripolar (truncated in the FDA record)	P010015/S589 FDA
2026-07-31	Medtronic, Inc.	Consulta CRT-P (C4TR01); Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1T (truncated in the FDA record)	P010015/S588 FDA
2026-07-23	Boston Scientific	ESSENTIO™ MRI SR SL (L110); ESSENTIO™ MRI DR SL (L111); ESSENTIO™ MRI DR EL (L131); PROPONENT™ MRI SR SL (L210); PROPONE (truncated in the FDA record)	P150012/S189 FDA
2026-07-23	Boston Scientific Corp	ESSENTIO™ SR SL (L100); ESSENTIO™ DR SL (L101); ESSENTIO™ DR EL (L121); PROPONENT™ SR SL (L200); PROPONENT™ DR SL (L201)	N970003/S309 FDA
2026-07-21	ABBOTT MEDICAL	Assurity MRI / Endurity MRI Pacemakers	P140033/S101 FDA
2026-07-16	Medtronic, Inc.	Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (truncated in the FDA record)	P010015/S587 FDA
2026-07-01	Boston Scientific	INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI	P150012/S182 FDA
2026-07-01	Boston Scientific Corp	ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2	N970003/S307 FDA
2026-06-09	Boston Scientific	LD INGEVITY™ PLUS AF	P150012/S188 FDA
2026-06-03	Boston Scientific	Ingevity MRI Leads: Ingevity MRI Lead Models: 7731, 7732, 7735, 7736, 7740, 7741, 7742 Ingevity+ Lead Models: 7831, 7832 (truncated in the FDA record)	P150012/S186 FDA
2026-06-03	Boston Scientific	ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI	P150012/S185 FDA
2026-06-03	Boston Scientific Corp	ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE	N970003/S308 FDA
2026-06-01	Boston Scientific	INGEVITYTM+ Lead Passive Models	P150012/S187 FDA
2026-05-19	Boston Scientific	INGEVITY™ MRI; INGEVITY™+; INGEVITY™+ Passive	P150012/S184 FDA
2026-05-15	Boston Scientific	Stylet Models (5003, 5004, 5005, 5012, 5013, 5014); INGEVITY™ Attachable Suture Sleeve (aka Lead Stabilizer) (Model 6402 (truncated in the FDA record)	P150012/S183 FDA
2026-05-14	Medtronic, Inc.	Percepta Bipolar CRT-P (WlTR0l); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (WlTR02); Serena Quadripolar (truncated in the FDA record)	P010015/S583 FDA
2026-04-30	Medtronic, Inc.	Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena Quadripolar (truncated in the FDA record)	P010015/S581 FDA
2026-04-24	ABBOTT MEDICAL	Assurity MRI, Endurity MRI family of Pacemakers	P140033/S102 FDA
2026-04-23	Medtronic, Inc.	Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRTP (W1TR02); Serena Quadripolar C (truncated in the FDA record)	P010015/S585 FDA
2026-04-15	Medtronic, Inc.	Attain Bipolar OTW Lead; Attain OTW L V Lead	P010015/S586 FDA
2026-04-10	Boston Scientific	• Lead Stylets, Straight, X-Soft Models 5003, 5004, 5005 • Lead Stylets, Long Tapered, Soft Models 5012, 5013, 5014	P150012/S181 FDA
2026-04-01	Boston Scientific Corp	PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE	N970003/S306 FDA
2026-03-27	Medtronic, Inc.	Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P (truncated in the FDA record)	P010015/S584 FDA
2026-03-18	Boston Scientific	INGEVITY™+ Pace / Sense Lead – Tined Fixation Models 7831 (52 cm, Straight) 7832 (59 cm, Straight) 7835 (45 cm, Atrial J (truncated in the FDA record)	P150012/S178 FDA
2026-03-06	Medtronic, Inc.	Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P (truncated in the FDA record)	P010015/S582 FDA
2026-02-13	Boston Scientific	INGEVITY™ MRI/ model 7731; INGEVITY™ MRI/ model 7732; INGEVITY™ MRI/ model 7735; INGEVITY™ MRI/ model 7736; INGEVITY™ MR (truncated in the FDA record)	P150012/S179 FDA
2026-02-12	Medtronic, Inc.	Consulta CRT-P C4TR01 Syncra CRT-P C2TR01	P010015/S580 FDA
2026-02-10	Medtronic, Inc.	Attain OTW LV Lead; Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Qua (truncated in the FDA record)	P010015/S579 FDA
2026-02-10	Medtronic, Inc.	Consulta CRT-P (C4TR01); Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1T (truncated in the FDA record)	P010015/S578 FDA
2026-01-23	Medtronic, Inc.	Percepta Bipolar CRT-P; Perceota Quadrioolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P (truncated in the FDA record)	P010015/S577 FDA
2026-01-23	Medtronic, Inc.	Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRTP; Serena Quadripolar CRT-P; Solar (truncated in the FDA record)	P010015/S576 FDA
2026-01-09	Boston Scientific	INGEVITY™ Family Bradycardia Leads	P150012/S177 FDA
2026-01-08	Boston Scientific	Accolade MRI Pacemakers- ACCOLADE MRI Models: L310, L311, L331; ESSENTIO MRI Models: L110, L111, L131; PROPONENT Models: (truncated in the FDA record)	P150012/S169 FDA
2026-01-08	Boston Scientific Corp	Accolade Pacemakers: ACCOLADE Models: L300, L301, L321; ALTRUA 2 Models: S701, S702, S722; ESSENTIO Models: L100, L101, (truncated in the FDA record)	N970003/S301 FDA
2017-01-31	ABBOTT MEDICAL	Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software	P140033 FDA
2016-04-25	Boston Scientific	IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD	P150012 FDA
2001-08-28	Medtronic, Inc.	MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM	P010015 FDA
1999-06-03	Boston Scientific Corp	PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE	N970003 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

LWP 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:LWP

{
  "id": "fda_product_code:LWP",
  "vocabulary": "fda_product_code",
  "term": "LWP",
  "definition": "Implantable Pulse Generator, Pacemaker (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:LWP",
  "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": "2026-09-20T01:19:14.871164+00:00",
  "updated_at": "2026-09-20T01:19:00.568+00:00"
}

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