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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameINTERGEL ADHESION PREVENTION SOLUTION
Classification Namebarrier, absorable, adhesion
Generic Nameabsorbable adhesion barrier
ApplicantLIFECORE BIOMEDICAL, INC.
PMA NumberP990015
Date Received03/08/1999
Decision Date11/16/2001
Withdrawal Date 12/11/2007
Product Code
MCN[ Registered Establishments with MCN ]
Docket Number 01M-0523
Notice Date 11/21/2001
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the gynecare intergel adhesion preventiion solution. The device is indicated for use in patients undergoing open, conservative gynecologic surgery as an adjunct to good surgical technique to reduce post-surgical adhesions. Gynecare intergel adhesion prevention solution is also intended to reduce the likelihood of developing moderate or severe postoperative adnexal adhesions in these patients.
Approval Order Approval Order
Supplements: S001 S002 
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