, BRAVA QUAD, CONCERTO II , CONSULTA , MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S & XT, VIVA S & XT CRT-D'S
FDA premarket approval P010031/S466 · decided 2014-11-14
Approval details
- PMA number
- P010031
- Supplement
- S466
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- , BRAVA QUAD, CONCERTO II , CONSULTA , MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S & XT, VIVA S & XT CRT-D'S
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2014-09-02
- Decision date
- 2014-11-14
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE DESIGN AND MANUFACTURING CHANGES OF THE 9-PIN FEEDTHROUGH SUBASSEMBLY IN THE PMA SUPPLEMENTS.
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