Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D
FDA premarket approval P010031/S863 · decided 2025-02-20
Approval details
- PMA number
- P010031
- Supplement
- S863
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- 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)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2024-07-15
- Decision date
- 2025-02-20
- Days to decision
- 220 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- approval for an alternate material suppler for polyurethane resin used in the manufacture of implantable defibrillator headers.
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