Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | SEPRAFILM ADHESION BARRIER |
Generic Name | Barrier, absorbable, adhesion |
Applicant | Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
PMA Number | P950034 |
Supplement Number | S022 |
Date Received | 09/24/2002 |
Decision Date | 10/25/2002 |
Product Code |
MCN |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REVISED LABELING FOR SEPRAFILM ADHESION BARRIER TO REFLECT THE INTERIM FINDINGS OF THE STUDY APPROVED UNDER G980066, "A PROSPECTIVE, RANDOMIZED, MULTICENTER, CONTROLLED EVALUATION OF THE EFFICACY AND SAFETY OF SEPRAFILM BIORESORBABLE MEMBRANE IN THE REDUCTION OF THE INCIDENCE OF BOWEL OBSTRUCTION OF GENERAL SURGERY." THE DEVICE, WITH THE MODIFIED LABELING, WILL BE MARKETED UNDER THE TRADE NAME SEPRAFILM ADHESION BARRIER, AND IS INDICATED FOR USE IN PATIENTS UNDERGOING ABDOMINAL OR PELVIC LAPAROTOMY AS AN ADJUNCT INTENDED TO REDUCE THE INCIDENCE, EXTENT, AND SEVERITY OF POSTOPERATIVE ADHESIONS BETWEEN THE ABDOMINAL WALL AND THE UNDERLYING VISCERA SUCH AS OMENTUM, SMALL BOWEL, BLADDER AND STOMACH, AND BETWEEN THE UTERUS AND SURROUNDING STRUCTURES SUCH AS TUBES AND OVARIES, LARGE BOWEL, AND BLADDER. |
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