INSYNC MARQUIS/SENTRY/MAXIMO/CONCERTO & VIRTUOSO CRT-ICDS
FDA premarket approval P010031/S061 · decided 2007-01-30
Approval details
- PMA number
- P010031
- Supplement
- S061
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INSYNC MARQUIS/SENTRY/MAXIMO/CONCERTO & VIRTUOSO CRT-ICDS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2006-12-20
- Decision date
- 2007-01-30
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC MODELS 2490G (REV. T APPLICATION SOFTWARE VERSION 5V3); MEDTRONIC 2020A CARDIOSIGHT READER (APPLICATION SOFTWARE VERSION 5V3); AND MEDTRONIC 2491 DDMA SOFTWARE. THE MEDTRONIC 2491 DDMA SOFTWARE CONTAINS THE XML TRANSLATION UTILITY (XMLTU) SOFTWARE VERSION V17, THE PRESENTING WAVEFORM UTILITY (PWF) SOFTWARE VERSION 16V1, AND THE SESSION DATA DECODE (SDD) SOFTWARE VERSION 1V2.
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