CONCERTO/II/CONSULTA/INSYNC ICD/INSYNC MARQUIS/MAXIMO/INSYNC II MARQUIS/MAXIMO II/INSYNC II PROTECT/III MARQUIS/SENTRY
FDA premarket approval P010031/S206 · decided 2010-11-10
Approval details
- PMA number
- P010031
- Supplement
- S206
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCERTO/II/CONSULTA/INSYNC ICD/INSYNC MARQUIS/MAXIMO/INSYNC II MARQUIS/MAXIMO II/INSYNC II PROTECT/III MARQUIS/SENTRY
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2010-06-28
- Decision date
- 2010-11-10
- Days to decision
- 135 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR IMPLEMENTATION OF A NEW RELEASE OF TRACEABILITY SOFTWARE.
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