CONSULTA CRT-P, SYNCRA CRT-P
FDA premarket approval P010015/S237 · decided 2014-05-23
Approval details
- PMA number
- P010015
- Supplement
- S237
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONSULTA CRT-P, SYNCRA CRT-P
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- Medtronic, Inc.
- Date received
- 2014-03-28
- Decision date
- 2014-05-23
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR FIRMWARE UPDATES TO THE MYCARELINK PATIENT MONITOR24950.
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