BRAVA,BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S, VIVA QUAD XT, VIVA S, VIVA XT CR
FDA premarket approval P010031/S492 · decided 2015-03-03
Approval details
- PMA number
- P010031
- Supplement
- S492
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BRAVA,BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S, VIVA QUAD XT, VIVA S, VIVA XT CR
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-02-05
- Decision date
- 2015-03-03
- Days to decision
- 26 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- UPDATES TO THE INTEGRATED CIRCUIT TEST SOFTWARE AND TEST PROCESS.
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