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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 NumberS001
Date Received04/18/2002
Decision Date07/09/2002
Product Code
MCN[ Registered Establishments with MCN ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR AN ADDITIONAL MANUFACTURING FACILITY FOR THE BLOW/FILL/SEAL AND ASEPTIC FILLING OF THE GYNECARE INTERGEL ADHESION PREVENTION SOLUTION. THE FACILITY IS LOCATED AT CARDINAL HEALTH MANUFACTURING SERVICES, AUTOMATIC LIQUID PACKAGING, INC., WOODSTOCK, ILLINOIS.
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