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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
Classification Namebarrier, absorable, adhesion
Generic Namebarrier, absorable, adhesion
Applicant
LIFECORE BIOMEDICAL, INC.
3515 lyman blvd.
chaska, MN 55318
PMA NumberP990015
Supplement NumberS002
Date Received09/19/2002
Decision Date03/18/2003
Product Code
MCN[ Registered Establishments with MCN ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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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