INSYNC II/III MARQUIS/INSYNC II/III PROTECT/INSYNC SENTRY/MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DS
FDA premarket approval P010031/S191 · decided 2010-05-11
Approval details
- PMA number
- P010031
- Supplement
- S191
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INSYNC II/III MARQUIS/INSYNC II/III PROTECT/INSYNC SENTRY/MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2010-03-01
- Decision date
- 2010-05-11
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR ENHANCEMENTS TO THE MODEL 9986 SOFTWARE. THE MODEL 9986 SOFTWARE IS THE DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
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