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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namestent, bladder, fetal
Generic Namestent, bladder, fetal
Cook Incorporated
750 daniels way
p.o. box 489
bloomington, IN 47402
HDE NumberH960001
Date Received11/13/1996
Decision Date02/14/1997
Product Code
MPR[ Registered Establishments with MPR ]
Docket Number 97M-0124
Notice Date 04/07/1997
Advisory Committee Obstetrics/Gynecology
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the harrison fetal bladder stent (lowery modification). This device is indicated for fetal urinary tract decompression following the diagnosis of fetal post-vesicular obstructive uropathy in fetuses of 18 to 32 weeks gestational age.
Approval Order Approval Order
Supplements: S001 S003