PMA P990046S054
- Device
- Open Pivot Mechanical Heart Valve; Open Pivot Aortic Valved Graft
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S054
- Product code
- LWQ
- Decision date
- 2018-07-11
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Transfer of manufacturing operations to a different building within the same manufacturing site.
Current openFDA PMA Record#
- Device
- Open Pivot Mechanical Heart Valve; Open Pivot Aortic Valved Graft
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S054
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2018-07-11
- Decision code
- OK30
- Date received
- 2018-06-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer of manufacturing operations to a different building within the same manufacturing site.