BRAVA CRT-D, BRAVA QUARD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, XT CRT-D, VIVA QUAD
FDA premarket approval P010031/S482 · decided 2015-02-07
Approval details
- PMA number
- P010031
- Supplement
- S482
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BRAVA CRT-D, BRAVA QUARD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, XT CRT-D, VIVA QUAD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-01-20
- Decision date
- 2015-02-07
- Days to decision
- 18 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- MINOR UPDATE TO THE SOFTWARE CONFIGURATION OF THE INTEGRATED CIRCUIT DIE SORTER EQUIPMENT.
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