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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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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 HDE to get an up-to-date view of this device.
 
Trade NameRocket KCH Fetal Bladder Drain
Classification Namestent, bladder, fetal
Generic Namestent, bladder, fetal
Applicant
Rocket Medical Plc
1151 hope st.
stamford, CT 06907
HDE NumberH970001
Supplement NumberS002
Date Received09/19/2019
Decision Date10/16/2019
Product Code
MPR[ Registered Establishments with MPR ]
Advisory Committee Obstetrics/Gynecology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for changes to the professional instructions for use to include an additional warning statement regarding off-label use and revisions to the directions for use including an expanded caution statement to address complaints related to device kinking.
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