|
Device | ST. JUDE MEDICAL MECHANICAL HEART VALVE |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | Abbott Medical 177 County Road B. East St. Paul, MN 55117 |
PMA Number | P810002 |
Supplement Number | S042 |
Date Received | 04/17/1996 |
Decision Date | 05/14/1996 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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 |