SEPRAFILM ADHESION BARRIER

FDA premarket approval P950034/S037 · decided 2011-01-19

Approval details

PMA number

P950034

Supplement

S037

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

SEPRAFILM ADHESION BARRIER

Generic name

Barrier, absorbable, adhesion

Applicant

Baxter Healthcare Corporation

Date received

2010-10-29

Decision date

2011-01-19

Days to decision

82 days

Decision code

APPR

Product code

MCN

Advisory committee

General, Plastic Surgery

Expedited review

No

Location

Deerfield Lake, IL

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

510(k) clearances by this applicant