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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.
 
DeviceHYSKON HYSTEROSCOPY FLUID 32% (W/V) DEXTRAN 70 IN DEXTROSE
Generic NameFLUID, HYSTEROSCOPY
ApplicantCoopervision Surgical
95 Corporate Dr.
Trumbull, CT 06611
PMA NumberN17511
Supplement NumberS015
Date Received04/08/2008
Decision Date05/14/2008
Withdrawal Date04/14/2009
Product Code LTA 
Advisory Committee Obstetrics/Gynecology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO THE EQUIPMENT USED FOR CAPPING VIALS.
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