PMA P950034S022

Device: SEPRAFILM ADHESION BARRIER
Applicant: Baxter Healthcare Corporation
PMA number: P950034
Supplement: S022
Product code: MCN
Decision date: 2002-10-25
Generic name: Barrier, absorbable, adhesion
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.

Current openFDA PMA Record#

Device: SEPRAFILM ADHESION BARRIER
Applicant: Baxter Healthcare Corporation
PMA number: P950034
Supplement: S022
Product code: MCN
Generic name: Barrier, absorbable, adhesion
Decision date: 2002-10-25
Decision code: APPR
Date received: 2002-09-24
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.