INSYNC/INSYNC II/INSYNC III MARQUIS/INSYNC II PROTECT/INSYNC SENTRY/INSYNC MAXIMO ICDS/CONCERTO & II/MAXIMO II/CONSULTA
FDA premarket approval P010031/S174 · decided 2009-12-30
Approval details
- PMA number
- P010031
- Supplement
- S174
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INSYNC/INSYNC II/INSYNC III MARQUIS/INSYNC II PROTECT/INSYNC SENTRY/INSYNC MAXIMO ICDS/CONCERTO & II/MAXIMO II/CONSULTA
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2009-12-02
- Decision date
- 2009-12-30
- Days to decision
- 28 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE IN THE MEAN POWER PARAMETER FOR A LASER WELDING MANUFACTURING OPERATION.
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