INSYNC MARQUIS, INSYNC SENTRY, AND INSYNC MAXIMO FAMILIES
FDA premarket approval P010031/S080 · decided 2007-11-09
Approval details
- PMA number
- P010031
- Supplement
- S080
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INSYNC MARQUIS, INSYNC SENTRY, AND INSYNC MAXIMO FAMILIES
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2007-09-24
- Decision date
- 2007-11-09
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS-PENANG, PENANG, MALAYSIA.
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