- Device
- Open Pivot Mechanical Valve (OPHV), Open Pivot Aortic Valved Graft (AVG)
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S062
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2022-03-10
- Decision code
- OK30
- Date received
- 2022-02-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New yarn extrusion and compounding suppliers and automation of the scouring process for the polyester yarn components.