INSYNC,CONSULTA,AND SYNCRA FAMILIES OF IPGS
FDA premarket approval P010015/S175 · decided 2012-09-25
Approval details
- PMA number
- P010015
- Supplement
- S175
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INSYNC,CONSULTA,AND SYNCRA FAMILIES OF IPGS
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Applicant
- Medtronic, Inc.
- Date received
- 2012-08-24
- Decision date
- 2012-09-25
- Days to decision
- 32 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 2490C MEDTRONIC CARELINK REMOTE HOME MONITOR, THE MODEL 2020A MEDTRONIC CARDIOSIGHT READER, AND THE MODEL 2020B CARELINK EXPRESS MONITOR.
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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