- Device
- Medtronic Open Pivot Mechanical Valve (OPHV), Medtronic Open Pivot Aortic Valved Graft (AVG)
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S060
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2022-01-20
- Decision code
- APPR
- Date received
- 2021-06-21
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change to the formulation of a detergent used to clean valve orifices and leaflets.