SEPRAFILM ADHESION BARRIER

FDA premarket approval P950034/S027 · decided 2007-07-11

Approval details

PMA number

P950034

Supplement

S027

Supplement type

Normal 180 Day Track No User Fee

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

SEPRAFILM ADHESION BARRIER

Generic name

Barrier, absorbable, adhesion

Applicant

Baxter Healthcare Corporation

Date received

2005-01-06

Decision date

2007-07-11

Days to decision

916 days

Decision code

APPR

Product code

MCN

Advisory committee

General, Plastic Surgery

Expedited review

No

Location

Deerfield Lake, IL

Statement

APPROVAL FOR LABELING CHANGES. THE DEVICE, AS MODIFIED, 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 BLADD

510(k) clearances by this applicant