PMA P990046S043
- Device
- OPEN PIVOT AORTIC VALVED GRAFT
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S043
- Product code
- LWQ
- Decision date
- 2015-12-16
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- A CHANGE TO THE BIOBURDEN MONITORING STRATEGY AND STERILITY VERIFICATION DOSE MONITORING.
Current openFDA PMA Record#
- Device
- OPEN PIVOT AORTIC VALVED GRAFT
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S043
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2015-12-16
- Decision code
- OK30
- Date received
- 2015-11-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- A CHANGE TO THE BIOBURDEN MONITORING STRATEGY AND STERILITY VERIFICATION DOSE MONITORING.