CONCERTO II/CONSULTA/MAXIMO II CRT-DS
FDA premarket approval P010031/S198 · decided 2011-03-22
Approval details
- PMA number
- P010031
- Supplement
- S198
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONCERTO II/CONSULTA/MAXIMO II CRT-DS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2010-05-17
- Decision date
- 2011-03-22
- Days to decision
- 309 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE CHANGE OF THE MATERIALS, POWER SUPPLY, AND INCOMING INSPECTIONPROCESS FOR THE FOLLOWING AVX CAPACITORS TO BE USED IN THE ABOVE REFERENCED IPGS. THOSE CAPACITORS ARE: XT009, XT045, XT082, XT096, XT113, XTC002, XTC018, XTC029, XT014,XT053, XT084, XT097, XT114, XTC004, XTC019, XTC030, XT017, XT058, XT085, XT099,XT116, XTC005, XTC020, XT023, XT060, XT086, XT103, XT118, XTC006, XTC021,XT027, XT067, XT087, XT104, XT120, XTC007, XTC023, XT032, XT068, XT088, XT105,XT121, XTC008, XTC024,
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