ACUITY™ X4 Suture Sleeve (aka Lead Stabilizer) (Model 4603); ACUITY™ X4 Flushing Tool/Wire Guide (Model 4604)

Supplement S608 to premarket approval P010012. Product code NIK. Decision 15 May 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	P010012	pma_number
Supplement number	S608	supplement_number
Applicant	Boston Scientific Corp	applicant
Trade name	ACUITY™ X4 Suture Sleeve (aka Lead Stabilizer) (Model 4603); ACUITY™ X4 Flushing Tool/Wire Guide (Model 4604)	trade_name
Generic name	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)	generic_name
Product code	NIK	product_code
Advisory committee	Cardiovascular	advisory_committee_description
Date received	2026-04-17	date_received
Decision date	2026-05-15	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, P010012/S608, retrieved 2026-09-19 21:55 Eastern. Public domain (CC0).

Product code

The FDA classification record for the code on this record.

NIK

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

Device class 3 · Review panel CV

All records with this codeClassification record on FDA

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.

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
P010012 FDA	original approval	empty	2002-05-02
P010012/S612 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2026-08-25
P010012/S613 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-07-23
P010012/S607 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2026-07-01
P010012/S611 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-06-09
P010012/S610 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-06-03
P010012/S609 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-06-03
P010012/S608 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-05-15
P010012/S606 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-04-22
P010012/S594 FDA	Normal 180 Day Track	Change Design/Components/Specifications/Material	2026-04-21
P010012/S604 FDA	Real-Time Process	Labeling Change - Indications/instructions/shelf life/tradename	2026-04-10
P010012/S605 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-04-01
P010012/S602 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-02-13
P010012/S592 FDA	135 Review Track For 30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-01-08

Source: FDA openFDA, device/pma, records of P010012, retrieved 2026-09-19 21:55 Eastern. 14 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.

Resolution

No verified alias in ArrHub’s table; the name stands as the register spells it.

First seen by ArrHub’s weekly snapshot: 2026-09-20 08:40 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:P010012+AND+supplement_number:S608&limit=1

{
  "id": "40fd90e3-a15c-434a-ab16-79df4ab7a907",
  "pma_key": "P010012/S608",
  "pma_number": "P010012",
  "supplement_number": "S608",
  "applicant": "Boston Scientific Corp",
  "trade_name": "ACUITY X4 Suture Sleeve (aka Lead Stabilizer) (Model 4603); ACUITY X4 Flushing Tool/Wire Guide (Model 4604)",
  "generic_name": "Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)",
  "product_code": "NIK",
  "advisory_committee_description": "Cardiovascular",
  "decision_date": "2026-05-15",
  "decision_code": "OK30",
  "supplement_type": "30-Day Notice",
  "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
  "date_received": "2026-04-17",
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010012&s=S608",
  "verified_at": "2026-09-20T02:04:11.743+00:00",
  "created_at": "2026-09-20T01:55:41.466163+00:00",
  "collected_at": "2026-09-20T01:55:27.157+00:00",
  "last_checked_at": null
}

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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