SEPRAFILM ADHESION BARRIER

FDA premarket approval P950034/S022 · decided 2002-10-25

Approval details

PMA number

P950034

Supplement

S022

Supplement type

Real-Time Process

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

2002-09-24

Decision date

2002-10-25

Days to decision

31 days

Decision code

APPR

Product code

MCN

Advisory committee

General, Plastic Surgery

Expedited review

No

Location

Deerfield Lake, IL

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 P

510(k) clearances by this applicant