PMA P830039S010
- Device
- OMNISCIENCE CARDIAC VALVE
- Applicant
- Medical Cv, Inc.
- PMA number
- P830039
- Supplement
- S010
- Product code
- LWQ
- Decision date
- 1999-10-29
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Approval for modifications to the Omni-Series Instructions for Handling and Use.
Current openFDA PMA Record#
- Device
- OMNISCIENCE CARDIAC VALVE
- Applicant
- Medical Cv, Inc.
- PMA number
- P830039
- Supplement
- S010
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 1999-10-29
- Decision code
- APPR
- Date received
- 1999-05-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for modifications to the Omni-Series Instructions for Handling and Use.