CONSULTA CRT D,MAXIMO II CRT-D,CONCERTO II CRT-D,CONCERTO CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA XT CRT-D,VIVA S,BR
FDA premarket approval P010031/S392 · decided 2013-10-07
Approval details
- PMA number
- P010031
- Supplement
- S392
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONSULTA CRT D,MAXIMO II CRT-D,CONCERTO II CRT-D,CONCERTO CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA XT CRT-D,VIVA S,BR
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-08-06
- Decision date
- 2013-10-07
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A FIRMWARE UPDATE TO THE MODEL 2490C CARELINK REMOTE HOME MONITOR FOR THE DEVICES.
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