CONCERT II, CONSULTA, & MAXIMO II CRT-DS
FDA premarket approval P010031/S296 · decided 2012-06-04
Approval details
- PMA number
- P010031
- Supplement
- S296
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONCERT II, CONSULTA, & MAXIMO II CRT-DS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-03-07
- Decision date
- 2012-06-04
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR CONCERTO II CRT-D MODEL D274TRK, CONSULTA CRT-D MODELS D204TRM AND D224TRK AND MAXIMO II CRT-D MODELS D264TRM AND D284TRK.
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