CONCERT II/CONSULTA/INSYNC II/III MARQUIS/MAXIMO/SENTRY/MAXIMO II PROTECTA/XT/INSYNC MARQUIS/INSYNC II PROTECT/CONCERTO
FDA premarket approval P010031/S280 · decided 2011-12-06
Approval details
- PMA number
- P010031
- Supplement
- S280
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONCERT II/CONSULTA/INSYNC II/III MARQUIS/MAXIMO/SENTRY/MAXIMO II PROTECTA/XT/INSYNC MARQUIS/INSYNC II PROTECT/CONCERTO
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-11-10
- Decision date
- 2011-12-06
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- NIK
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.