Cobalt MRI CRT-D DTPB2D1, DTPB2D4 NIK Cobalt XT MRI CRT-D DTPA2D1, DTPA2D4 NIK Crome MRI CRT-D DTPC2D1, DTPC2D4
FDA premarket approval P010031/S905 · decided 2025-12-19
Approval details
- PMA number
- P010031
- Supplement
- S905
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Cobalt MRI CRT-D DTPB2D1, DTPB2D4 NIK Cobalt XT MRI CRT-D DTPA2D1, DTPA2D4 NIK Crome MRI CRT-D DTPC2D1, DTPC2D4
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2025-09-25
- Decision date
- 2025-12-19
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- approval for a material change in the pulse generator header components of select CRT-D and CRT-P devices.
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