INSYNC MARQUIS/INSYNC III (MARQUIS)/INSYNC II (MARQUIS)/INSYNC II (PROTECT)/INSYNC MAXIMO/PRODIGY DR
FDA premarket approval P010031/S016 · decided 2004-09-22
Approval details
- PMA number
- P010031
- Supplement
- S016
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INSYNC MARQUIS/INSYNC III (MARQUIS)/INSYNC II (MARQUIS)/INSYNC II (PROTECT)/INSYNC MAXIMO/PRODIGY DR
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2004-08-27
- Decision date
- 2004-09-22
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE IN THE STERILIZATION PROCESS.
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