PMA P990046S059
- Device
- Open Pivot Aortic Valved Graft
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S059
- Product code
- LWQ
- Decision date
- 2021-07-29
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Approval for changes to the inner packaging design and extension of the shelf life.
Current openFDA PMA Record#
- Device
- Open Pivot Aortic Valved Graft
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S059
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2021-07-29
- Decision code
- APPR
- Date received
- 2021-05-06
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to the inner packaging design and extension of the shelf life.