Cobalt MRI CRTD, Cobalt XT MRI CRT-D, Crome MRI CRT-D
FDA premarket approval P010031/S854 · decided 2024-06-17
Approval details
- PMA number
- P010031
- Supplement
- S854
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Cobalt MRI CRTD, 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
- 2024-03-19
- Decision date
- 2024-06-17
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- approval of minor design updates to the connector assemblies and Bluetooth antenna in the Cobalt/Crome device families
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.