PMA P990046S037
- Device
- OPEN PIVOT HEART VALVE AND AORTIC VALVE GRAFT
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S037
- Product code
- LWQ
- Decision date
- 2014-01-24
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- ALTERNATIVE TO BATCH TESTING FOR BACTERIAL ENDOTOXIN TESTING (BET).
Current openFDA PMA Record#
- Device
- OPEN PIVOT HEART VALVE AND AORTIC VALVE GRAFT
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S037
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2014-01-24
- Decision code
- OK30
- Date received
- 2013-12-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATIVE TO BATCH TESTING FOR BACTERIAL ENDOTOXIN TESTING (BET).