INSYNC CRT-D/CONCERTO & VARIOUS INSYNC FAMILIES OF ICDS
FDA premarket approval P010031/S115 · decided 2009-04-21
Approval details
- PMA number
- P010031
- Supplement
- S115
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INSYNC CRT-D/CONCERTO & VARIOUS INSYNC FAMILIES OF ICDS
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2008-08-04
- Decision date
- 2009-04-21
- Days to decision
- 260 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL OF THE ADDITION OF AN ETHYLENE OXIDE STERILIZER.
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