CONSULTA,SYNCRA,VIVA CRT-PS,INSYNC IPG
FDA premarket approval P010015/S255 · decided 2015-10-19
Approval details
- PMA number
- P010015
- Supplement
- S255
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONSULTA,SYNCRA,VIVA CRT-PS,INSYNC IPG
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- Medtronic, Inc.
- Date received
- 2014-12-22
- Decision date
- 2015-10-19
- Days to decision
- 301 days
- Decision code
- APPR
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE REMOTE CONTROL SOFTWARE ON THE 2090 PROGRAMMER.
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