INSYNC FAMILIES OF CRT-ICD'S, INSYNC MAXIMO, INSYNC SENTRY FAMILY, INSYNC II PROTECT, INSYNC III MARQUIS FAMILY, INSYNC
FDA premarket approval P010031/S039 · decided 2006-05-08
Approval details
- PMA number
- P010031
- Supplement
- S039
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INSYNC FAMILIES OF CRT-ICD'S, INSYNC MAXIMO, INSYNC SENTRY FAMILY, INSYNC II PROTECT, INSYNC III MARQUIS FAMILY, INSYNC
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2006-04-10
- Decision date
- 2006-05-08
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE ADDITION OF THE SUPPORT FOR THE INSYNC III MARQUIS TO THE 2490G CARELINK MONITOR AND THE 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) SOFTWARE, AND THE UPDATES TO THE FIRMWARE USED IN THE 2490G CARELINK MONITOR AND UPDATES TO THE 2491 DDMA SOFTWARE.
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