PSW 2601.U, NEO 2601.U

Supplement S179 to premarket approval P070008. Product code NKE. Decision 17 September 2026.

Approval

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
PMA number	P070008	pma_number
Supplement number	S179	supplement_number
Applicant	Biotronik, Inc.	applicant
Trade name	PSW 2601.U, NEO 2601.U	trade_name
Generic name	Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)	generic_name
Product code	NKE	product_code
Advisory committee	Cardiovascular	advisory_committee_description
Date received	2026-04-15	date_received
Decision date	2026-09-17	decision_date
Decision code	APPR	decision_code
Supplement type	Real-Time Process	supplement_type
Supplement reason	Change Design/Components/Specifications/Material	supplement_reason

Source: FDA openFDA, device/pma, P070008/S179, retrieved 2026-10-15 16:01 Eastern. Public domain (CC0).

Product code

The FDA classification record for the code on this record.

NKE

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

Device class 3 · Review panel CV

All records with this codeClassification record on FDA

ArrHub vocabulary

Electrophysiology

NKE is one of the 60 product codes in ArrHub’s electrophysiology vocabulary, each held with its FDA classification record as its citation. Vocabulary entry verified 20 September 2026.

Supplement history

Every record of this PMA number in ArrHub’s verified view, newest first. Routine notices are listed, never summarised away.

Record	Type	Reason	Decision
P070008 FDA	original approval	empty	2008-05-12
P070008/S172 FDA	Normal 180 Day Track	Change Design/Components/Specifications/Material	2026-09-25
P070008/S179 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2026-09-17
P070008/S178 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-05-07
P070008/S175 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2026-04-24
P070008/S176 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-03-05
P070008/S174 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-02-03

Source: FDA openFDA, device/pma, records of P070008, retrieved 2026-10-15 16:01 Eastern. 7 records in the verified view. Each identifier links to the FDA’s page.

ArrHub

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

Record pair

No confirmed pair across the two registers for this record.

Resolved to

Biotronik

The register name above is resolved to its organisation under ArrHub’s alias table. Method: rule:normalize. Source: fda_applicant. Verified 20 September 2026.

First seen by ArrHub’s weekly snapshot: 2026-10-15 17:24 Eastern.

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/pma.json?search=pma_number:P070008+AND+supplement_number:S179&limit=1

{
  "id": "a26f10cb-2176-4b54-927d-f719aae92f3e",
  "pma_key": "P070008/S179",
  "pma_number": "P070008",
  "supplement_number": "S179",
  "applicant": "Biotronik, Inc.",
  "trade_name": "PSW 2601.U, NEO 2601.U",
  "generic_name": "Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)",
  "product_code": "NKE",
  "advisory_committee_description": "Cardiovascular",
  "decision_date": "2026-09-17",
  "decision_code": "APPR",
  "supplement_type": "Real-Time Process",
  "supplement_reason": "Change Design/Components/Specifications/Material",
  "date_received": "2026-04-15",
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P070008&s=S179",
  "verified_at": "2026-10-15T21:05:45.031+00:00",
  "created_at": "2026-10-15T20:01:55.624421+00:00",
  "collected_at": "2026-10-15T20:01:55.441+00:00",
  "last_checked_at": "2026-10-15T21:05:45.031+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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