VALITUDE™ (Model U125); VALITUDE X4 (Model U128); VISIONIST™ (Models U225, U226); VISIONIST X4 (Model U228)

Supplement S257 to premarket approval P030005. Product code NKE. Decision 3 October 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	P030005	pma_number
Supplement number	S257	supplement_number
Applicant	Guidant Corp.	applicant
Trade name	VALITUDE™ (Model U125); VALITUDE X4 (Model U128); VISIONIST™ (Models U225, U226); VISIONIST X4 (Model U228)	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	2026-09-15	date_received
Decision date	2026-10-03	decision_date
Decision code	OK30	decision_code
Supplement type	30-Day Notice	supplement_type
Supplement reason	Process Change - Manufacturer/Sterilizer/Packager/Supplier	supplement_reason

Source: FDA openFDA, device/pma, P030005/S257, 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
P030005 FDA	original approval	empty	2004-01-26
P030005/S257 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-10-03
P030005/S255 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-07-23
P030005/S253 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2026-07-01
P030005/S254 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-06-03
P030005/S252 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-04-01
P030005/S247 FDA	135 Review Track For 30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-01-08

Source: FDA openFDA, device/pma, records of P030005, 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

Boston Scientific

The register name above is resolved to its organisation under ArrHub’s alias table. Method: manual:m&a. 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:P030005+AND+supplement_number:S257&limit=1

{
  "id": "9f147a3e-dd09-49a9-9c72-9be70ab7cad6",
  "pma_key": "P030005/S257",
  "pma_number": "P030005",
  "supplement_number": "S257",
  "applicant": "Guidant Corp.",
  "trade_name": "VALITUDE (Model U125); VALITUDE X4 (Model U128); VISIONIST (Models U225, U226); VISIONIST X4 (Model U228)",
  "generic_name": "Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)",
  "product_code": "NKE",
  "advisory_committee_description": "Cardiovascular",
  "decision_date": "2026-10-03",
  "decision_code": "OK30",
  "supplement_type": "30-Day Notice",
  "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
  "date_received": "2026-09-15",
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030005&s=S257",
  "verified_at": "2026-10-15T21:05:21.529+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": "2026-10-15T21:05:21.529+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.