PMA P990046S020
- Device
- ATS OPEN PIVOT HEART VALVE
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S020
- Product code
- LWQ
- Decision date
- 2009-03-24
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- ALTERNATE LOCATION FOR ASSEMBLY OF THE SEWING CUFF COMPONENT AT THE LAKE FOREST FACILITY.
Current openFDA PMA Record#
- Device
- ATS OPEN PIVOT HEART VALVE
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S020
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2009-03-24
- Decision code
- OK30
- Date received
- 2009-03-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE LOCATION FOR ASSEMBLY OF THE SEWING CUFF COMPONENT AT THE LAKE FOREST FACILITY.