Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

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	NIK	product_code
Device name	Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	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 NIK, 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 Corp	Tachy Pulse Generators	P010012/S612 FDA
2026-08-12	ABBOTT MEDICAL	Avant (CDHFA700Q, CDHFA700B, CDHFA700D, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800B, CDHFA800D, CDHFA800T, CDHFA600Q, (truncated in the FDA record)	P030054/S446 FDA
2026-07-31	Medtronic Cardiac Rhythm Disease Management	Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4) Brava Quad (truncated in the FDA record)	P010031/S930 FDA
2026-07-31	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRTD (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Crome MR (truncated in the FDA record)	P010031/S929 FDA
2026-07-31	Medtronic Cardiac Rhythm Disease Management	Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4);Brava Quad (truncated in the FDA record)	P010031/S928 FDA
2026-07-23	Boston Scientific Corp	MOMENTUM™ CRT-D IS1 DF4 IS1 (G124, G125); MOMENTUM™ CRT-D IS1 DF1 LV1 (G126); MOMENTUM™ X4 CRT-D IS1 DF1 IS4 (G128, G138 (truncated in the FDA record)	P010012/S613 FDA
2026-07-22	Medtronic Cardiac Rhythm Disease Management	Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRTD DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D1, DTBC1D4; Brava Quad CRT-D (truncated in the FDA record)	P010031/S927 FDA
2026-07-21	ABBOTT MEDICAL	Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+	P030054/S440 FDA
2026-07-16	Medtronic Cardiac Rhythm Disease Management	Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt (truncated in the FDA record)	P010031/S926 FDA
2026-07-09	ABBOTT MEDICAL	Avant (CDHFA700Q, CDHFA700T, CDHFA700D); Neutrino NxT (CDHFA800Q, CDHFA800T, CDHFA800B, CDHFA800D, CDHFA600Q, CDHFA600T, (truncated in the FDA record)	P030054/S445 FDA
2026-07-01	Boston Scientific Corp	COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT	P010012/S607 FDA
2026-06-25	Medtronic Cardiac Rhythm Disease Management	Amplia MRI CRT-D DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D4 Brava Quad CRT-D DTBC1Q1, DTBC1QQ Cl (truncated in the FDA record)	P010031/S922 FDA
2026-06-09	Boston Scientific Corp	ACUITY™ SPIRAL, ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L	P010012/S611 FDA
2026-06-03	Boston Scientific Corp	EasyTrak, Acuity Spiral and Acuity x4 Leads: ACuity Spiral Lead Model: 4592 Acuity x4 Lead Models: 4671, 4672, 4674, 467 (truncated in the FDA record)	P010012/S610 FDA
2026-06-03	Boston Scientific Corp	MOMENTUM, MOMENTUM X4, INOGEN, DYNAGEN, VIGILANT, VIGILANT X4, RESONATE, RESONATE X4, RESONATE HF	P010012/S609 FDA
2026-05-15	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRTD (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Cobalt X (truncated in the FDA record)	P010031/S925 FDA
2026-05-15	Boston Scientific Corp	ACUITY™ X4 Suture Sleeve (aka Lead Stabilizer) (Model 4603); ACUITY™ X4 Flushing Tool/Wire Guide (Model 4604)	P010012/S608 FDA
2026-04-30	Medtronic Cardiac Rhythm Disease Management	Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt (truncated in the FDA record)	P010031/S924 FDA
2026-04-30	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRT-D (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Crome M (truncated in the FDA record)	P010031/S918 FDA
2026-04-28	Medtronic Cardiac Rhythm Disease Management	Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt (truncated in the FDA record)	P010031/S923 FDA
2026-04-24	ABBOTT MEDICAL	Optisure Leads (LDA210, LDA210Q, LDA220Q, LDP210Q, LDP220Q, LDA230Q, LDP230Q); Quartet Leads (1456Q, 1457Q, 1458Q, 1456Q (truncated in the FDA record)	P030054/S444 FDA
2026-04-24	ABBOTT MEDICAL	Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+	P030054/S442 FDA
2026-04-22	Boston Scientific Corp	ACUITY Spiral (Model 4592); ACUITY X4 Straight (Model 4593); ACUITY X4 Straight (Model 4672); ACUITY X4 Spiral S (Model (truncated in the FDA record)	P010012/S606 FDA
2026-04-21	Boston Scientific Corp	Cardiac Resynchronization Therapy Defibrillators (CRT-D) RESONATE: G524, G525, G526, G528, G537, G547, G548, G424, G425, (truncated in the FDA record)	P010012/S594 FDA
2026-04-10	Boston Scientific Corp	Suture Sleeve Model 4603, 6402 , ACUITY X4 Flushing tool/Wire guide Model 4604, Lead Cap Model 6742, Torque Wrench, Mode (truncated in the FDA record)	P010012/S604 FDA
2026-04-01	Boston Scientific Corp	CONTAK CD, EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILL (truncated in the FDA record)	P010012/S605 FDA
2026-03-27	ABBOTT MEDICAL	Avant (CDHFA700Q, CDHFA700B, CDHFA700D, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800B, CDHFA800D, CDHFA800T); Gallant ( (truncated in the FDA record)	P030054/S443 FDA
2026-03-27	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D	P010031/S921 FDA
2026-03-06	Medtronic Cardiac Rhythm Disease Management	Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt (truncated in the FDA record)	P010031/S920 FDA
2026-03-04	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI CRT-D (DTPB2Dl, DTPB2D4, DTPB2Ql, DTPB2QQ); Cobalt XT MRI CRT-D (DTPA2Dl, DTPA2D4, DTPA2Ql, DTPA2QQ); Crome M (truncated in the FDA record)	P010031/S919 FDA
2026-02-19	ABBOTT MEDICAL	Quartet; QuickFlex Micro	P030054/S435 FDA
2026-02-13	ABBOTT MEDICAL	Avant (CDHFA700Q, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800T CDHFA600Q, CDHFA600T); Gallant (CDHFA500Q, CDHFA500T); (truncated in the FDA record)	P030054/S441 FDA
2026-02-13	Boston Scientific Corp	ACUITY™ X4 Straight/ model 4671; ACUITY X4 Straight/ model 4672; ACUITY X4 Spiral S/ model 4674; ACUITY X4 Spiral S/ mod (truncated in the FDA record)	P010012/S602 FDA
2026-02-12	Medtronic Cardiac Rhythm Disease Management	Amplia MRI CRT-D DTMB1D1, DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D1, DTBC1D4 Brava Quad CRT-D D (truncated in the FDA record)	P010031/S916 FDA
2026-02-11	Medtronic Cardiac Rhythm Disease Management	Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt (truncated in the FDA record)	P010031/S914 FDA
2026-02-10	Medtronic Cardiac Rhythm Disease Management	Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt (truncated in the FDA record)	P010031/S915 FDA
2026-01-23	Medtronic Cardiac Rhythm Disease Management	Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt (truncated in the FDA record)	P010031/S912 FDA
2026-01-16	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D	P010031/S913 FDA
2026-01-08	Boston Scientific Corp	NG3 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds): DYNAGEN Models: G150, G151, G154, G156, G158; INOGEN Mode (truncated in the FDA record)	P010012/S592 FDA
2026-01-05	Medtronic Cardiac Rhythm Disease Management	Amplia MRI CRT-D DTMB1D1, DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D1, DTBC1D4 Brava Quad CRT-D D (truncated in the FDA record)	P010031/S911 FDA
2004-06-30	ABBOTT MEDICAL	ST JUDE MEDICAL EPIC HF SYSTEM	P030054 FDA
2002-06-26	Medtronic Cardiac Rhythm Disease Management	CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION	P010031 FDA
2002-05-02	Boston Scientific Corp	CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (truncated in the FDA record)	P010012 FDA

510(k) clearances with this code

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None in the verified view.

ArrHub

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ArrHub vocabulary

Electrophysiology

NIK 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:NIK

{
  "id": "fda_product_code:NIK",
  "vocabulary": "fda_product_code",
  "term": "NIK",
  "definition": "Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)",
  "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:NIK",
  "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": "2026-09-20T01:09:16.160243+00:00",
  "updated_at": "2026-09-20T01:19:10.927+00:00"
}

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