PMA P990046S047
- Device
- OPEN PIVOT HEART VALVE & OPEN PIVOT AORTIC VALVED GRAFT
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S047
- Product code
- LWQ
- Decision date
- 2016-08-04
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Update to software used in the manufacturing process for the Open Pivot Heart Valve and Aortic Valved Graft.
Current openFDA PMA Record#
- Device
- OPEN PIVOT HEART VALVE & OPEN PIVOT AORTIC VALVED GRAFT
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S047
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2016-08-04
- Decision code
- OK30
- Date received
- 2016-07-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update to software used in the manufacturing process for the Open Pivot Heart Valve and Aortic Valved Graft.