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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSEPRAFILM BIORESORBABLE MEMBRANE
Generic NameBarrier, absorbable, adhesion
ApplicantBaxter Healthcare Corporation
One Baxter Parkway
Deerfield, IL 60015
PMA NumberP950034
Supplement NumberS020
Date Received08/29/2001
Decision Date09/28/2001
Product Code MCN 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE INVOLVING CONVERTING THE SEPRAFILM MANUFACTURING AREA FROM A DEDICATED AREA TO A SHARED AREA SHERE STERILE HYALURONIC ACID (HA) WILL BE PRODUCED. THERE WILL BE NO IMPACT ON THE MANUFACTURING PROCESSES WITH THE PROPER CLEANING OF THE THREE VESSELS. THE CLEANING PROCESS HAS BEEN VALIDATED.
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