CONCERTO/CONCERTO II/CONSULTA/INSYNC II/III MARQUIS/MAXIMO/SENTRY/MAXIMO II/PROTECTA/PROTECTA XT
FDA premarket approval P010031/S258 · decided 2011-07-07
Approval details
- PMA number
- P010031
- Supplement
- S258
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCERTO/CONCERTO II/CONSULTA/INSYNC II/III MARQUIS/MAXIMO/SENTRY/MAXIMO II/PROTECTA/PROTECTA XT
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-06-08
- Decision date
- 2011-07-07
- Days to decision
- 29 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC).
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