CONCERTO II/CONSULTA/INSYNC II MARQUIS/III MARQUIS/INSYNC MAXIMO/SENTRY/MAXIMO II/PROTECTA/PROTECTA XT
FDA premarket approval P010031/S252 · decided 2011-08-18
Approval details
- PMA number
- P010031
- Supplement
- S252
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONCERTO II/CONSULTA/INSYNC II MARQUIS/III MARQUIS/INSYNC MAXIMO/SENTRY/MAXIMO II/PROTECTA/PROTECTA XT
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-04-28
- Decision date
- 2011-08-18
- Days to decision
- 112 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR DESIGN, MATERIALS, AND MANUFACTURING CHANGES TO THE HYBRIDS USED IN THE GEN2 AND ADAMS HYBRID PLATFORMS.
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