PMA P990046S027
- Device
- OPEN PIVOT AORTIC VALVED GRAFT
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S027
- Product code
- LWQ
- Decision date
- 2012-04-03
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- APPROVAL FOR ADDING TEXT TO THE OPEN PIVOT AORTIC VALVED GRAFT INSTRUCTIONS FOR USE (IFU) TO STRENGTHEN THE CAUTERIZATION PRECAUTION STATEMENT.
Current openFDA PMA Record#
- Device
- OPEN PIVOT AORTIC VALVED GRAFT
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S027
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2012-04-03
- Decision code
- APPR
- Date received
- 2012-03-08
- Supplement type
- Special (Immediate Track)
- Approval order statement
- APPROVAL FOR ADDING TEXT TO THE OPEN PIVOT AORTIC VALVED GRAFT INSTRUCTIONS FOR USE (IFU) TO STRENGTHEN THE CAUTERIZATION PRECAUTION STATEMENT.