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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 NumberS001
Date Received04/18/2002
Decision Date07/09/2002
Withdrawal Date 12/11/2007
Product Code MCN 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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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