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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
Generic NameFLUID, HYSTEROSCOPY
ApplicantCoopervision Surgical
95 Corporate Dr.
Trumbull, CT 06611
PMA NumberN17511
Supplement NumberS014
Date Received03/19/2001
Decision Date08/17/2001
Withdrawal Date04/14/2009
Product Code LTA 
Advisory Committee Obstetrics/Gynecology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A NEW WATER FOR INJECTION(WFI) GENERATION SYSTEM FOR THE WFI COMPONENT OF THE HYSKON(R) HYSTEROSCOPY FLUID.
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