CONCERTO/INSYNC SENTRY/INSYNC MAXIMO
FDA premarket approval P010031/S104 · decided 2008-08-28
Approval details
- PMA number
- P010031
- Supplement
- S104
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONCERTO/INSYNC SENTRY/INSYNC MAXIMO
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2008-06-09
- Decision date
- 2008-08-28
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE RV LEAD INTEGRITY ALERT (RVLIA) FEATURE AND MODEL SW012, VERSION 1.0, RVLIA SOFTWARE.
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