BRAVA CRT-D; CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D , PROTECTA CRT-D,PROTECTA XT CRT-D, VIVA S CRT-D, VIVA XT
FDA premarket approval P010031/S450 · decided 2014-07-09
Approval details
- PMA number
- P010031
- Supplement
- S450
- Supplement type
- 30-Day Notice
- Trade name
- BRAVA CRT-D; CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D , PROTECTA CRT-D,PROTECTA XT CRT-D, VIVA S CRT-D, VIVA XT
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2014-06-20
- Decision date
- 2014-07-09
- Days to decision
- 19 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- REDUCTION OF SONOSCAN DETECTION METHOD FOR THE DEVICES.
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