INSYNC SENTRY FAMILY/INSYNC II/III MARQUIS/INSYNC II/III PROTECT/INSYNC MAXIMO FAMILY/CONCERTO
FDA premarket approval P010031/S112 · decided 2008-08-22
Approval details
- PMA number
- P010031
- Supplement
- S112
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INSYNC SENTRY FAMILY/INSYNC II/III MARQUIS/INSYNC II/III PROTECT/INSYNC MAXIMO FAMILY/CONCERTO
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2008-07-23
- Decision date
- 2008-08-22
- Days to decision
- 30 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- REQUESTED A NEW PHOTO DEVELOPER RECIPE.
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