ST. JUDE MEDICAL MECHANICAL HEART VALVE
FDA premarket approval P810002/S042 · decided 1996-05-14
Approval details
- PMA number
- P810002
- Supplement
- S042
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ST. JUDE MEDICAL MECHANICAL HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- ABBOTT MEDICAL
- Date received
- 1996-04-17
- Decision date
- 1996-05-14
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR LABELING CHANGE TO THE ST. JUDE MEDICAL COATED AORTIC VALVED GRAFT (CAVG), MODEL CAVG-404. THE WARNING WILL INSTRUCT THE PHYSICIAN TO WET THE GRAFT WITH SLINE BEFORE CAUTERIZING IN ORDER TO PREVENT IGNITION
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