INSYNC II PROTECT/SENTRY/MARQUIS/MAXIMO ICDS/CONCERTO/CONSULTA/MAXIMO II/CONCERTO II CRT-DS
FDA premarket approval P010031/S185 · decided 2010-03-05
Approval details
- PMA number
- P010031
- Supplement
- S185
- Supplement type
- 30-Day Notice
- Trade name
- INSYNC II PROTECT/SENTRY/MARQUIS/MAXIMO ICDS/CONCERTO/CONSULTA/MAXIMO II/CONCERTO II CRT-DS
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2010-02-05
- Decision date
- 2010-03-05
- Days to decision
- 28 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE IN A VENDOR¿S EPITAXY SUPPLIER.
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