PMA P990046S066
- Device
- Medtronic Open Pivot Aortic Valved Graft (AVG)
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S066
- Product code
- LWQ
- Decision date
- 2023-07-19
- Classification
- Cardiovascular
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Change to a sub-tier supplier of a Teleflex suture component used on the Open Pivot Aortic Valved Graft (AVG).
Current openFDA PMA Record#
- Device
- Medtronic Open Pivot Aortic Valved Graft (AVG)
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S066
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2023-07-19
- Decision code
- OK30
- Date received
- 2023-06-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to a sub-tier supplier of a Teleflex suture component used on the Open Pivot Aortic Valved Graft (AVG).