Cobalt MRI CRT-D, Cobalt XT MRI CRT-D and Crome MRI CRT-D
FDA premarket approval P010031/S771 · decided 2022-02-22
Approval details
- PMA number
- P010031
- Supplement
- S771
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Cobalt MRI CRT-D, Cobalt XT MRI CRT-D and Crome MRI CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2022-01-28
- Decision date
- 2022-02-22
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Updates the accept/reject criteria for anode shifting and spacer non-conformances and addition of pictures and descriptions of defect codes.
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