Amplia MRI/Quad, Brava/Quad, Claria MRI/Quad, Compia MRI/Quad, Consulta, Protecta/XT, Viava Quad S/XT, Viva S/XT CRT-D
FDA premarket approval P010031/S677 · decided 2019-08-06
Approval details
- PMA number
- P010031
- Supplement
- S677
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Amplia MRI/Quad, Brava/Quad, Claria MRI/Quad, Compia MRI/Quad, Consulta, Protecta/XT, Viava Quad S/XT, Viva S/XT CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2019-07-12
- Decision date
- 2019-08-06
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Implementation of process controls for Soft Straight-Line Finish (SLF) cosmetic work.
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