Cobalt MRI CRT-D DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ; Cobalt XT MRI CRTD DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ; Crome MRI CR
FDA premarket approval P010031/S904 · decided 2025-10-03
Approval details
- PMA number
- P010031
- Supplement
- S904
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Cobalt MRI CRT-D DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ; Cobalt XT MRI CRTD DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ; Crome MRI CR
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2025-09-23
- Decision date
- 2025-10-03
- Days to decision
- 10 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- updating visual inspection criteria for the cathode manufacturing process
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.