CONSULTA & SYNCRA CRT-PS IMPLANTABLE PULSE GENERATOR WITH CARDIAC RESYNCHRONIZATION
FDA premarket approval P010015/S084 · decided 2011-03-22
Approval details
- PMA number
- P010015
- Supplement
- S084
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONSULTA & SYNCRA CRT-PS IMPLANTABLE PULSE GENERATOR WITH CARDIAC RESYNCHRONIZATION
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- Medtronic, Inc.
- Date received
- 2010-03-31
- Decision date
- 2011-03-22
- Days to decision
- 356 days
- Decision code
- APPR
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE CONSULTA CRT-P C4TR01 AND SYNCRA CRT-P C2TR01 IMPLANTABLE PULSE GENERATORS WITH CARDIAC RESYNCHRONIZATION, SOFTWARE MODEL 9995 (VERSION 7.3), CARELINK MONITOR MODELS 2490G AND MODEL 2491 DDMA.
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