CONCERTO/CONCERTO II/CONSULTA/INSYNC II & III MARQUIS/INSYNC MAXIMO/INSYNC SENTRY/MAXIMO PROTECTA/PROTECTA XT
FDA premarket approval P010031/S276 · decided 2011-10-13
Approval details
- PMA number
- P010031
- Supplement
- S276
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCERTO/CONCERTO II/CONSULTA/INSYNC II & III MARQUIS/INSYNC MAXIMO/INSYNC SENTRY/MAXIMO PROTECTA/PROTECTA XT
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-09-16
- Decision date
- 2011-10-13
- Days to decision
- 27 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- SOFTWARE UPDATES FOR A TESTING APPLICATION.
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