Cobalt MRI CRT-P, Cobalt XT MRI CRT-D, Crome MRI CRT-D
FDA premarket approval P010031/S714 · decided 2020-09-15
Approval details
- PMA number
- P010031
- Supplement
- S714
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Cobalt MRI CRT-P, 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
- 2020-08-19
- Decision date
- 2020-09-15
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Add a second supplier of raw shields, shield monitors and shield assemblies for Percepta, Serena and Solara devices and to add a second supplier of shield assemblies for Cobalt and Crome devices.
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