CONSULTA CRT-P & SYNCRA CRT-P
FDA premarket approval P010015/S145 · decided 2011-12-06
Approval details
- PMA number
- P010015
- Supplement
- S145
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONSULTA CRT-P & SYNCRA CRT-P
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Applicant
- Medtronic, Inc.
- Date received
- 2011-11-10
- Decision date
- 2011-12-06
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- OJX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR FIRMWARE UPDATES TO THE MODEL 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR, MODEL 2020A MEDTRONIC CARDIOSIGHT READER AND MODEL 2020B CARELINK EXPRESS MONITOR.
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