Concerto ICD, Concerto II CRT-D, Conslta DR4 ICD, Consulta ICD, InSync Maximo ICD, Maximo II CRT-D, Protecta CRT-D, Prot
FDA premarket approval P010031/S600 · decided 2017-10-25
Approval details
- PMA number
- P010031
- Supplement
- S600
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Concerto ICD, Concerto II CRT-D, Conslta DR4 ICD, Consulta ICD, InSync Maximo ICD, Maximo II CRT-D, Protecta CRT-D, Prot
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2017-09-01
- Decision date
- 2017-10-25
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for several updates to the web-based battery longevity tool.
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