Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

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	NKE	product_code
Device name	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	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 NKE, 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
2026-07-23	Guidant Corp.	VALITUDE™ CRT-P IS1 EL (U125); VALITUDE™ CRT-P IS4 EL (U128); VISIONIST™ CRT-P IS1 EL (U225); VISIONIST™ CRT-P LV1 EL (U (truncated in the FDA record)	P030005/S255 FDA
2026-07-21	ABBOTT MEDICAL	Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps	P030035/S211 FDA
2026-07-01	Guidant Corp.	INVIVE, INTUA, VISIONIST, VALITUDE	P030005/S253 FDA
2026-06-03	Guidant Corp.	VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4	P030005/S254 FDA
2026-05-07	Biotronik, Inc.	Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Amvia Sky HF-T, Amvia Sky (truncated in the FDA record)	P070008/S178 FDA
2026-04-24	Biotronik, Inc.	Renamic Neo	P070008/S175 FDA
2026-04-24	ABBOTT MEDICAL	Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps	P030035/S212 FDA
2026-04-01	Guidant Corp.	CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE	P030005/S252 FDA
2026-03-05	Biotronik, Inc.	Edora 8 HF-T QP (407137); Edora 8 HF-T (407138); Evity 8 HF-T QP (407139); Evity 8 HF-T (407140); Enitra 8 HF-T QP (4071 (truncated in the FDA record)	P070008/S176 FDA
2026-02-03	Biotronik, Inc.	STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD	P070008/S174 FDA
2026-01-08	Guidant Corp.	Accolade CRT – Pacemakers (CRT-Ps): VALITUDE CRT-P U125; VALITUDE X4 CRT-P Model U128; VISIONIST CRT-P Models U225, U226 (truncated in the FDA record)	P030005/S247 FDA
2008-05-12	Biotronik, Inc.	STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD	P070008 FDA
2004-05-13	ABBOTT MEDICAL	ANTHEM AND FRONTIER II CRT-P'S	P030035 FDA
2004-01-26	Guidant Corp.	CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE	P030005 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

NKE 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:NKE

{
  "id": "fda_product_code:NKE",
  "vocabulary": "fda_product_code",
  "term": "NKE",
  "definition": "Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)",
  "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:NKE",
  "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": "2026-09-20T01:19:15.303838+00:00",
  "updated_at": "2026-09-20T01:19:01.016+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.

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