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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceABSORBABLE ADHESION BARRIER
Classification Namebarrier, absorable, adhesion
Generic Namebarrier, absorable, adhesion
Applicant
ETHICON, INC.
route 22 west
p.o. box 151
somerville, NJ 08876-0151
PMA NumberP880047
Supplement NumberS015
Date Received04/18/2011
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/material
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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