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. |
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Device | REPRO-MED - THD |
Generic Name | DEVICE, TESTICULAR HYPOTHERMIA |
Applicant | REPRO-MED SYSTEMS, INC. 24 CARPENTER RD. CHESTER, NY 10918 |
PMA Number | P820034 |
Supplement Number | S004 |
Date Received | 06/08/1992 |
Decision Date | 04/29/1993 |
Withdrawal Date
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01/04/2024 |
Product Code |
LOA |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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