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/S491 · decided 2015-03-01
Approval details
- PMA number
- P010031
- Supplement
- S491
- 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
- 2015-03-01
- Days to decision
- 24 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- UPDATE THE FINAL VISUAL INSPECTION CRITERIA FOR THE HYBRIDS USED IN THE DEVICES.
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