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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 NumberS027
Date Received01/06/2005
Decision Date07/11/2007
Product Code
MCN[ Registered Establishments with MCN ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes. The device, as modified, will be marketed under the trade name seprafilm adhesion barrier and is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.
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