PMA P990046S034
- Device
- OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S034
- Product code
- LWQ
- Decision date
- 2013-07-30
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- APPROVAL FOR REVISING THE LIST OF POTENTIAL ADVERSE EVENTS IN THE INSTRUCTIONS FOR USE.
Current openFDA PMA Record#
- Device
- OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S034
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2013-07-30
- Decision code
- APPR
- Date received
- 2013-07-01
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISING THE LIST OF POTENTIAL ADVERSE EVENTS IN THE INSTRUCTIONS FOR USE.