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
FDA premarket approval P010031/S376 · decided 2013-07-15
Approval details
- PMA number
- P010031
- Supplement
- S376
- Supplement type
- Real-Time Process
- 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
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-05-13
- Decision date
- 2013-07-15
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR CELLULAR CONNECTIVITY FOR REMOTE MONITORING WITH MODEL 2020A CARDIOSIGHT READER AND MODELS 2020B, 2020C MEDTRONIC CARELINK EXPRESS MONITORS.
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