INSYNC II MARQUIS
FDA premarket approval P010031/S085 · decided 2007-12-04
Approval details
- PMA number
- P010031
- Supplement
- S085
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INSYNC II MARQUIS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2007-11-16
- Decision date
- 2007-12-04
- Days to decision
- 18 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MINOR DESIGN CHANGES THAT ADD TWO ALTERNATE TANTALUM CAPACITORS (XTC017, XTC018) WITH INCREASED VOLTAGE RATINGS TO APPROVED DEVICE COMPONENTS. THE DESIGN MODIFICATIONS ARE INTENDED TO REDUCE MANUFACTURING YIELD LOSS AND ASSOCIATED REWORK.
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