PMA P990046S038
- Device
- OPEN PIVOT HEART VALVE (OPHV) AND OPEN PIVOT AORTIC VALVED GRAFT (OPAVG)
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S038
- Product code
- LWQ
- Decision date
- 2014-08-20
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- AN ALTERNATE VISION SYSTEM FOR IN-PROCESS INSPECTION OF LEAFLET COMPONENTS.
Current openFDA PMA Record#
- Device
- OPEN PIVOT HEART VALVE (OPHV) AND OPEN PIVOT AORTIC VALVED GRAFT (OPAVG)
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S038
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2014-08-20
- Decision code
- OK30
- Date received
- 2014-07-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- AN ALTERNATE VISION SYSTEM FOR IN-PROCESS INSPECTION OF LEAFLET COMPONENTS.