INSYNC MARQUIS MODEL 7277LINSYNC II MARQUIS MODEL 7289; INSYNC III MARQUIS MODEL 7279,INSYNC II PROTECT MODEL 7295; UNSY
FDA premarket approval P010031/S053 · decided 2006-11-15
Approval details
- PMA number
- P010031
- Supplement
- S053
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INSYNC MARQUIS MODEL 7277LINSYNC II MARQUIS MODEL 7289; INSYNC III MARQUIS MODEL 7279,INSYNC II PROTECT MODEL 7295; UNSY
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2006-10-10
- Decision date
- 2006-11-15
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE DESIGN CHANGE TO ADD ALTERNATE TANTALUM CAPACITOR (XTC018) ON THE HYBRID OF THE MEDTRONIC ICDS.
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