CONCERTO II CRT-D & VARIOUS FAMILIES OF MAXIMO II & PROTECTA CRT-DS' VARIOUS FAMILIES OF CONSULTA ICDS
FDA premarket approval P010031/S316 · decided 2012-07-25
Approval details
- PMA number
- P010031
- Supplement
- S316
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONCERTO II CRT-D & VARIOUS FAMILIES OF MAXIMO II & PROTECTA CRT-DS' VARIOUS FAMILIES OF CONSULTA ICDS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-06-29
- Decision date
- 2012-07-25
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN UPDATE TO THE L409 INTEGRATED CIRCUIT.
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