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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 NameABSORBABLE ADHESION BARRIER
Classification Namebarrier, absorable, adhesion
ApplicantETHICON, INC.
PMA NumberP880047
Supplement NumberS015
Date Received04/21/2011
Decision Date06/17/2011
Product Code
MCN[ Registered Establishments with MCN ]
Advisory Committee Obstetrics/Gynecology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a larger interceed product that measures 5¿x6¿ in size. The device, as modified, is indicated as an adjuvant in open (laparotomy) gynecologic pelvic surgery for reducing the incidence of postoperative pelvic adhesions after meticulous hemostasis is achieved.
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