PMA P990046S041
- Device
- OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S041
- Product code
- LWQ
- Decision date
- 2016-02-08
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Approval for modification to in-process inspection.
Current openFDA PMA Record#
- Device
- OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S041
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2016-02-08
- Decision code
- APPR
- Date received
- 2015-08-10
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for modification to in-process inspection.