MAXIMO II CRT-D, CONCERTO, CONCERTO II CRT-D, CONSULTA, INSYNC II & IIIMARQUIS, MAXIMO, SENTRY, MARQUIS INSYNC II PROTEC
FDA premarket approval P010031/S433 · decided 2014-05-16
Approval details
- PMA number
- P010031
- Supplement
- S433
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MAXIMO II CRT-D, CONCERTO, CONCERTO II CRT-D, CONSULTA, INSYNC II & IIIMARQUIS, MAXIMO, SENTRY, MARQUIS INSYNC II PROTEC
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2014-03-18
- Decision date
- 2014-05-16
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR FIRMWARE UPDATES (VERSION CM2490G_15V6) TO THE CARELINK MONITOR MODEL 2490G CARELINK HOME MONITORS, MODEL 2020A CARDIOSIGHT READER, AND MODEL 2020B CARELINK EXPRESS FOR A VARIETY OF IMPLANTED DEVICES.
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