Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D

Supplement S921 to premarket approval P010031. Product code NIK. Decision 27 March 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	P010031	pma_number
Supplement number	S921	supplement_number
Applicant	Medtronic Cardiac Rhythm Disease Management	applicant
Trade name	Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D	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	2026-03-10	date_received
Decision date	2026-03-27	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, P010031/S921, 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
P010031 FDA	original approval	empty	2002-06-26
P010031/S930 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-07-31
P010031/S929 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-07-31
P010031/S928 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-07-31
P010031/S927 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-07-22
P010031/S926 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-07-16
P010031/S922 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2026-06-25
P010031/S925 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-05-15
P010031/S924 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-04-30
P010031/S918 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2026-04-30
P010031/S923 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-04-28
P010031/S921 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-03-27
P010031/S920 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-03-06
P010031/S919 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-03-04
P010031/S916 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-02-12
P010031/S914 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-02-11
P010031/S915 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-02-10
P010031/S912 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-01-23
P010031/S913 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-01-16
P010031/S911 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-01-05

Source: FDA openFDA, device/pma, records of P010031, retrieved 2026-09-19 21:55 Eastern. 20 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

Medtronic

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

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:P010031+AND+supplement_number:S921&limit=1

{
  "id": "37d86691-cb10-4ad1-aa68-9df083f2e2a2",
  "pma_key": "P010031/S921",
  "pma_number": "P010031",
  "supplement_number": "S921",
  "applicant": "Medtronic Cardiac Rhythm Disease Management",
  "trade_name": "Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D",
  "generic_name": "Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)",
  "product_code": "NIK",
  "advisory_committee_description": "Cardiovascular",
  "decision_date": "2026-03-27",
  "decision_code": "OK30",
  "supplement_type": "30-Day Notice",
  "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
  "date_received": "2026-03-10",
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010031&s=S921",
  "verified_at": "2026-09-20T02:04:24.286+00:00",
  "created_at": "2026-09-20T01:55:37.743665+00:00",
  "collected_at": "2026-09-20T01:55:23.426+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.

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.