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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 NumberS022
Date Received09/24/2002
Decision Date10/25/2002
Product Code
MCN[ Registered Establishments with MCN ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revised labeling for seprafilm adhesion barrier to reflect the interim findings of the study approved under g980066, "a prospective, randomized, multicenter, controlled evaluation of the efficacy and safety of seprafilm bioresorbable membrane in the reduction of the incidence of bowel obstruction of general surgery. " the device, with the modified labeling, 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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