CONCERTO II/CONSULTA/MAXIMO II CRT-DS
FDA premarket approval P010031/S199 · decided 2010-07-15
Approval details
- PMA number
- P010031
- Supplement
- S199
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONCERTO 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
- 2010-05-20
- Decision date
- 2010-07-15
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN UPDATE TO COMPONENT PLANTING SPECIFICATION TITLED ¿MATERIAL, PLANTING, AND SURFACE FINISH REQUIREMENTS FOR TERMINALS FOR LASER RIBBON-BONDING (LRB), WIREBONDING (WB), AND PARALLEL GAP WELDING (PGW).¿ (REVISION O).
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