PMA P990046S022
- Device
- ATS OPEN PIVOT HEART VALVE & ATS OPEN PIVOT AORTIC VALVED GRAFT
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S022
- Product code
- LWQ
- Decision date
- 2010-08-13
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- APPROVAL FOR LABELING CHANGES INCLUDING CHANGES TO THE MRI COMPATIBILITY INFORMATION.
Current openFDA PMA Record#
- Device
- ATS OPEN PIVOT HEART VALVE & ATS OPEN PIVOT AORTIC VALVED GRAFT
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S022
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2010-08-13
- Decision code
- APPR
- Date received
- 2010-07-12
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES INCLUDING CHANGES TO THE MRI COMPATIBILITY INFORMATION.