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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceSEPRAFILM ADHESION BARRIER
Classification Namebarrier, absorable, adhesion
Generic Namebarrier, absorable, adhesion
Applicant
GENZYME CORP.
55 cambridge parkway
cambridge, MA 02142
PMA NumberP950034
Supplement NumberS021
Date Received03/01/2002
Decision Date03/26/2002
Product Code
MCN[ Registered Establishments with MCN ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Manufacturing change to replace the current manual cleaning process for removing residual manufacturing materials from equipment with a semi-automatic substrate washer. The semi-automatic substrate washer would decrease the time and labor used in the manufacturing cleaning process.
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