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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.
Classification Namedevice, testicular hypothermia
Generic Namedevice, testicular hypothermia
24 carpenter rd.
chester, NY 10918
PMA NumberP820034
Supplement NumberS005
Date Received12/12/1996
Decision Date01/14/1997
Product Code
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to move the manufacturing site located at repro-med systems, middletown, ny to repro-med systems, 24 carpenter rd. , chester, ny. This supplement qualified for review under the pma supplement pilot described in the 20-mar-96 "dear president or ceo" letter re: changes in manufacturing sites.