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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.
 
Trade NameSEPRAFILM ADHESION BARRIER
Classification Namebarrier, absorable, adhesion
Generic Namebarrier, absorbalble, adhesion
ApplicantGENZYME CORP.
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: manufacturing
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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