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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceREPRO-MED - THD
Generic NameDEVICE, TESTICULAR HYPOTHERMIA
ApplicantRepro-Med Systems, Inc.
24 Carpenter Rd.
New York, NY 10918
PMA NumberP820034
Supplement NumberS005
Date Received12/12/1996
Decision Date01/14/1997
Withdrawal Date01/04/2024
Product Code LOA 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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