CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D; PROTECTA CRT-D, PROTECTA XT CRT-D,
FDA premarket approval P010031/S518 · decided 2015-11-12
Approval details
- PMA number
- P010031
- Supplement
- S518
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D; PROTECTA CRT-D, PROTECTA XT CRT-D,
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-10-19
- Decision date
- 2015-11-12
- Days to decision
- 24 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- UPDATE TO THE MANUFACTURING TEST SOFTWARE FOR AN INTEGRATED CIRCUIT USED IN THE DEVICES.
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