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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 NameKCH Fetal Bladder Drainage Catheter
Classification Namestent, bladder, fetal
Generic Namestent, bladder, fetal
Applicant
ROCKET MEDICAL PLC
1151 hope st.
stamford, CT 06907
HDE NumberH970001
Supplement NumberS001
Date Received12/11/2017
Decision Date02/16/2018
Product Code
MPR[ Registered Establishments with MPR ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Changes to the professional and patient labeling.
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