PMA P830039S008
- Device
- OMNISCIENCE AND OMNICARBON CARDIAC VALVES
- Applicant
- Medical Cv, Inc.
- PMA number
- P830039
- Supplement
- S008
- Product code
- LWQ
- Decision date
- 1998-09-25
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Approval for modifications to various cleaning methods utilized during production of the Omniscience(R) valve to remove chlorofluorocarbon solvents.
Current openFDA PMA Record#
- Device
- OMNISCIENCE AND OMNICARBON CARDIAC VALVES
- Applicant
- Medical Cv, Inc.
- PMA number
- P830039
- Supplement
- S008
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 1998-09-25
- Decision code
- APPR
- Date received
- 1998-07-22
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for modifications to various cleaning methods utilized during production of the Omniscience(R) valve to remove chlorofluorocarbon solvents.