PMA P950034S037

Device: SEPRAFILM ADHESION BARRIER
Applicant: Baxter Healthcare Corporation
PMA number: P950034
Supplement: S037
Product code: MCN
Decision date: 2011-01-19
Generic name: Barrier, absorbable, adhesion
Approval order statement: APPROVAL FOR THE ADDITION OF A ¿QUARTER SHEET¿ CONFIGURATION TO THE SEPRAFILM ADHESION BARRIER PRODUCT LINE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ¿SEPRAFILM 4-SECTION¿ 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: S037
Product code: MCN
Generic name: Barrier, absorbable, adhesion
Decision date: 2011-01-19
Decision code: APPR
Date received: 2010-10-29
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF A ¿QUARTER SHEET¿ CONFIGURATION TO THE SEPRAFILM ADHESION BARRIER PRODUCT LINE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ¿SEPRAFILM 4-SECTION¿ 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.