PMA P990046S063
- Device
- Medtronic Open Pivot Heart Valve, Medtronic Open Pivot Aortic Valved Graft
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S063
- Product code
- LWQ
- Decision date
- 2022-03-11
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Update to optical inspection equipment to reduce the number of conforming samples that were rejected.
Current openFDA PMA Record#
- Device
- Medtronic Open Pivot Heart Valve, Medtronic Open Pivot Aortic Valved Graft
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S063
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2022-03-11
- Decision code
- OK30
- Date received
- 2022-03-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update to optical inspection equipment to reduce the number of conforming samples that were rejected.