PMA P990046S058
- Device
- Open Pivot Heart Valves and Open Pivot Aortic Valved Graft
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S058
- Product code
- LWQ
- Decision date
- 2021-04-22
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Implementation of a new graphite cutting method.
Current openFDA PMA Record#
- Device
- Open Pivot Heart Valves and Open Pivot Aortic Valved Graft
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S058
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2021-04-22
- Decision code
- OK30
- Date received
- 2021-03-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a new graphite cutting method.