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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.
 
DeviceGYNECARE INTERGEL ADHESION PREVENTION SOLUTION
Generic NameBarrier, absorbable, adhesion
ApplicantLIFECORE BIOMEDICAL, INC.
3515 LYMAN BLVD.
CHASKA, MN 55318
PMA NumberP990015
Supplement NumberS002
Date Received09/19/2002
Decision Date03/18/2003
Withdrawal Date 12/11/2007
Product Code MCN 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE LABELING IN RESPONSE TO ADVERSE EVENT REPORTS OF ADDITIONAL SURGERY, INCLUDING HYSTERECTOMY, THAT OCCURRED FOLLOWING POST-OPERATIVE PAIN, ASCITES, NON-INFECTIOUS PERITONITIS, AND/OR POSSIBLE DELAYED CLEARANCE OF GYNECARE INTERGEL.
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