Consulta CRT-P, Syncra CRT-P and Viva CRT-P
FDA premarket approval P010015/S369 · decided 2018-05-30
Approval details
- PMA number
- P010015
- Supplement
- S369
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Consulta CRT-P, Syncra CRT-P and Viva CRT-P
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2018-04-17
- Decision date
- 2018-05-30
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for updates to the Medtronic MyCareLink Patient Monitor Models 24950 and 24952.
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