CONCERTO CRT-D/CONCERTO II ICD/CONSULTA CRT-D/INSYNC II MARQUIS/PROTECT/INSYNC III MARQUIS/INSYNC MARQUIS/INSYNC MAXIMO
FDA premarket approval P010031/S235 · decided 2011-02-23
Approval details
- PMA number
- P010031
- Supplement
- S235
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCERTO CRT-D/CONCERTO II ICD/CONSULTA CRT-D/INSYNC II MARQUIS/PROTECT/INSYNC III MARQUIS/INSYNC MARQUIS/INSYNC MAXIMO
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-02-01
- Decision date
- 2011-02-23
- Days to decision
- 22 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- AUTOMATION OF AN ADDITIONAL PLATING LINE.
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