CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P
FDA premarket approval P010015/S248 · decided 2014-11-07
Approval details
- PMA number
- P010015
- Supplement
- S248
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- Medtronic, Inc.
- Date received
- 2014-08-27
- Decision date
- 2014-11-07
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE SOFTWARE VERSION R67 OF MYCARELINK PATIENT MONITOR 24950 TO BE USED WITH THE DEVICES.
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