PMA P990046S021
- Device
- ATS MEDICAL OPEN PIVOT BI-LEAFLET MECHANICAL HEART VALVE
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S021
- Product code
- LWQ
- Decision date
- 2009-05-12
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- ADDITIONAL CNC GRINDER.
Current openFDA PMA Record#
- Device
- ATS MEDICAL OPEN PIVOT BI-LEAFLET MECHANICAL HEART VALVE
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S021
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2009-05-12
- Decision code
- OK30
- Date received
- 2009-04-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITIONAL CNC GRINDER.