Implantable Cardioverter Defibrillator (Non-Crt)
Device class 3 · Review panel CV
FDA PMA supplement record
P980016/S946
Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD
Supplement S946 to premarket approval P980016. Product code LWS. Decision 16 January 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 | P980016 | pma_number |
| Supplement number | S946 | supplement_number |
| Applicant | Medtronic Cardiac Rhythm Disease Management | applicant |
| Trade name | Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD | trade_name |
| Generic name | Implantable cardioverter defibrillator (non-CRT) | generic_name |
| Product code | LWS | product_code |
| Advisory committee | Cardiovascular | advisory_committee_description |
| Date received | 2026-01-07 | date_received |
| Decision date | 2026-01-16 | 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, P980016/S946, retrieved 2026-09-19 21:55 Eastern. Public domain (CC0).
Product code
The FDA classification record for the code on this record.
ArrHub vocabulary
Electrophysiology
LWS 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 |
|---|---|---|---|
| P980016 FDA | original approval | empty | 1998-10-09 |
| P980016/S963 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-07-31 |
| P980016/S962 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-07-31 |
| P980016/S961 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-07-31 |
| P980016/S960 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-07-22 |
| P980016/S959 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-07-16 |
| P980016/S955 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2026-06-25 |
| P980016/S958 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-05-15 |
| P980016/S957 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-04-30 |
| P980016/S951 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2026-04-30 |
| P980016/S956 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-04-28 |
| P980016/S954 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-03-27 |
| P980016/S953 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-03-06 |
| P980016/S952 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-03-04 |
| P980016/S949 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-02-12 |
| P980016/S947 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-02-11 |
| P980016/S948 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-02-10 |
| P980016/S945 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-01-23 |
| P980016/S946 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-01-16 |
| P980016/S944 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-01-05 |
Source: FDA openFDA, device/pma, records of P980016, 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:P980016+AND+supplement_number:S946&limit=1
{
"id": "f2238f2f-dbf7-4813-a081-cb33ec35b36a",
"pma_key": "P980016/S946",
"pma_number": "P980016",
"supplement_number": "S946",
"applicant": "Medtronic Cardiac Rhythm Disease Management",
"trade_name": "Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD",
"generic_name": "Implantable cardioverter defibrillator (non-CRT)",
"product_code": "LWS",
"advisory_committee_description": "Cardiovascular",
"decision_date": "2026-01-16",
"decision_code": "OK30",
"supplement_type": "30-Day Notice",
"supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
"date_received": "2026-01-07",
"source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980016&s=S946",
"verified_at": "2026-09-20T01:57:31.321+00:00",
"created_at": "2026-09-20T01:55:34.052721+00:00",
"collected_at": "2026-09-20T01:55:19.73+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.
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