PMA P950034S017

Device: SEPRAFILM(R) BIORESORBABLE MEMBRAND
Applicant: Baxter Healthcare Corporation
PMA number: P950034
Supplement: S017
Product code: MCN
Decision date: 2000-12-20
Generic name: Barrier, absorbable, adhesion
Approval order 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.

Current openFDA PMA Record#

Device: SEPRAFILM(R) BIORESORBABLE MEMBRAND
Applicant: Baxter Healthcare Corporation
PMA number: P950034
Supplement: S017
Product code: MCN
Generic name: Barrier, absorbable, adhesion
Decision date: 2000-12-20
Decision code: APPR
Date received: 2000-11-28
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.