Brava CRT-D, Brava Quad CRT-D, Concerto ICD, Concerto II CRT-D, Consulta CRT-D, InSync II Protect ICD, Maximo II CRT-D,
FDA premarket approval P010031/S618 · decided 2018-04-24
Approval details
- PMA number
- P010031
- Supplement
- S618
- Supplement type
- Real-Time Process
- 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, InSync II Protect ICD, Maximo II CRT-D,
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2018-02-01
- Decision date
- 2018-04-24
- Days to decision
- 82 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for stability enhancements, security updates, and error mitigation for the MyCareLink Patient Monitor Model 24950 firmware.
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