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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameHYSKON HYSTEROSCOPY FLUID
Classification Namefluid, hysteroscopy
Generic Namehysteroscopy fluid
ApplicantCOOPERSURGICAL, INC.
PMA NumberN17511
Supplement NumberS014
Date Received03/19/2001
Decision Date08/17/2001
Product Code
LTA
Advisory Committee Obstetrics/Gynecology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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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