CONSULTA CRT-P, SYNCRA CRT-P
FDA premarket approval P010015/S215 · decided 2014-02-14
Approval details
- PMA number
- P010015
- Supplement
- S215
- Supplement type
- Normal 180 Day Track
- 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
- 2013-08-23
- Decision date
- 2014-02-14
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR UPDATES TO THE MEDTRONIC MYCARELINK PATIENT MONITOR MODEL24950, READER MODEL 24955, AND ACCESSORIES, MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) AND APPLICATION SOFTWARE SW026 TO SUPPORT MEDTRONIC¿S REVEAL LINQ INSERTABLE CARDIAC MONITORS (ICM).
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