Brava CRT-D; Brava Quad CRT-D; Concerto ICD,II CRT-D; Consulta CRT-D; InSync II Protect ICD; Maximo II CRT-D; Protecta X
FDA premarket approval P010031/S560 · decided 2016-11-17
Approval details
- PMA number
- P010031
- Supplement
- S560
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Brava CRT-D; Brava Quad CRT-D; Concerto ICD,II CRT-D; Consulta CRT-D; InSync II Protect ICD; Maximo II CRT-D; Protecta X
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-09-08
- Decision date
- 2016-11-17
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for software modification to the MyCareLink Patient Monitor Model 24950.
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