CONSULTA CRT-D, CONCERTO II CRT-D AND MAXIMO II CRT-D
FDA premarket approval P010031/S141 · decided 2009-03-11
Approval details
- PMA number
- P010031
- Supplement
- S141
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONSULTA CRT-D, CONCERTO II CRT-D AND MAXIMO II CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2009-01-16
- Decision date
- 2009-03-11
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE FOLLOWING MINOR DESIGN CHANGES:1) TWO (2) IC DESIGN CHANGES¿ L310 AND L3542) TWO (2) ALTERNATE COMPONENTS¿ DIODE CHANGE (CURRENTLY: XD423 AND PROPOSED: XD445)¿ INSULATED-GATE BIPOLAR TRANSISTOR (IGBT) CHANGE (CURRENTLY: XD405 ANDPROPOSED: XD447)3) PRINTED WIRE BOARD (PWB) CHANGES TO ACCOMMODATE THE ALTERNATE (XD445 DIODE ANDXD447 IGBT) COMPONENTS AND MANUFACTURABILITY IMPROVEMENTS.4) FOUR (4) ICS (L303, L310, L354, AND L409) TO BE TRANSFERRED TO AN ALTERNATIVE ICFABRICATION VEND
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