Atlas FDA

SEPRAFILM(R) BIORESORBABLE MEMBRAND

FDA premarket approval P950034/S017 · decided 2000-12-20

Approval details

PMA number
P950034
Supplement
S017
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
SEPRAFILM(R) BIORESORBABLE MEMBRAND
Generic name
Barrier, absorbable, adhesion
Applicant
Baxter Healthcare Corporation
Date received
2000-11-28
Decision date
2000-12-20
Days to decision
22 days
Decision code
APPR
Product code
MCN
Advisory committee
General, Plastic Surgery
Expedited review
No
Location
Deerfield Lake, IL
Statement
APPROVAL FOR A NEW SIZE OF SEPRAFILM(R) AND TO CHANGE THE NAME OF THE PRODUCT FROM SEPRAFILM(R) BIORESORBABLE MEMBRANE TO SEPRAFILM(R) ADHESION BARRIER. THE LABELING HAS BEEN MODIFIED TO REFLECT THE NEW NAME AND NEW SIZE AND THE PACKAGE INSERT WAS MODIFIED TO BE INCLUDED WITH BOTH SIZES. FURTHERMORE, THE LABELING HAS BEEN MODIFIED TO OMIT THE REFERENCE TO THE CLINICAL STUDY IN THE FOREIGN BODY PRECAUTION.

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