INSYNC II/III MARQUIS/INSYNC SENTRY/MAXIMO/II/CONCERTO/II/CONSULTA
FDA premarket approval P010031/S220 · decided 2010-12-08
Approval details
- PMA number
- P010031
- Supplement
- S220
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INSYNC II/III MARQUIS/INSYNC SENTRY/MAXIMO/II/CONCERTO/II/CONSULTA
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2010-11-12
- Decision date
- 2010-12-08
- Days to decision
- 26 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- UPDATE TO SUPPLIER QUALITY SOFTWARE.
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