CONCERTO/CONCERTO II/CONSULTA/DF4/INSYNC II/III/MAXIMO/SENTRY/MAXIMO II/II M4/PROTECTA XT/PROTECTA/PROTECTA XT M4/M4
FDA premarket approval P010031/S255 · decided 2011-06-09
Approval details
- PMA number
- P010031
- Supplement
- S255
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCERTO/CONCERTO II/CONSULTA/DF4/INSYNC II/III/MAXIMO/SENTRY/MAXIMO II/II M4/PROTECTA XT/PROTECTA/PROTECTA XT M4/M4
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-05-10
- Decision date
- 2011-06-09
- Days to decision
- 30 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- ADDITION OF AN ETHYLENE OXIDE (ETO) STERILIZER SYSTEM.
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