BRAVA CRT-D, CONCERTO ICD,CONCERTO II CRT-D,CONSULTA ICD,INSYNC II PROTECT ICD,INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD
FDA premarket approval P010031/S439 · decided 2014-05-29
Approval details
- PMA number
- P010031
- Supplement
- S439
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BRAVA CRT-D, CONCERTO ICD,CONCERTO II CRT-D,CONSULTA ICD,INSYNC II PROTECT ICD,INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2014-03-28
- Decision date
- 2014-05-29
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MINOR HARDWARE AND FIRMWARE CHANGES TO THE MYCARELINK PATIENT MONITOR MODEL 24955 RF HEAD FOR THE DEVICES.
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