CONCERTO
FDA premarket approval P010031/S088 · decided 2008-01-03
Approval details
- PMA number
- P010031
- Supplement
- S088
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONCERTO
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2007-12-10
- Decision date
- 2008-01-03
- Days to decision
- 24 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 ALTERNATE COMPONENTS, DIODES (XD433, XD445) AND CAPACITOR (AVX KYOCERA X5R), TO THE APPROVED DEVICE COMPONENTS FOR USE ON THE HYBRID AS WELL AS MINOR ASSOCIATED MODIFICATIONS TO THE SUBSTRATE. THE DESIGN MODIFICATIONS ARE INTENDED TO INCREASE SUPPLY LINE ROBUSTNESS, REDUCE COMPONENT COSTS, AND IMPROVE INCOMING COMPONENT QUALITY.
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