BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D; MAXIMO II CRT-D, PROTECTA CRT-D, PROTECT
FDA premarket approval P010031/S523 · decided 2016-05-03
Approval details
- PMA number
- P010031
- Supplement
- S523
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D; MAXIMO II CRT-D, PROTECTA CRT-D, PROTECT
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-12-01
- Decision date
- 2016-05-03
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the Model 31301 CareLink Express App.
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