Amplia MRI/Quad, Brava/Quad CRT-D, Claria MRI/Quad CRT-D, Compia MRI/Quad CRT-D, Consulta CRT-D, Maximo II CRT-D, Vivad
FDA premarket approval P010031/S598 · decided 2017-07-18
Approval details
- PMA number
- P010031
- Supplement
- S598
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Amplia MRI/Quad, Brava/Quad CRT-D, Claria MRI/Quad CRT-D, Compia MRI/Quad CRT-D, Consulta CRT-D, Maximo II CRT-D, Vivad
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2017-06-23
- Decision date
- 2017-07-18
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Update the manufacturing execution system (MES) to FACTORYworks (FW) Release 9.3 at Medtronic Swiss Manufacturing Operations.
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