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.
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.
| Device | REPRO-MED - THD |
| Generic Name | Device, Testicular Hypothermia |
| Applicant | REPRO-MED SYSTEMS, INC. |
| Date Received | 1996-12-12 |
| Decision Date | 1997-01-14 |
| PMA | P820034 |
| Supplement | S005 |
| Product Code | LOA |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | REPRO-MED SYSTEMS, INC. 24 Carpenter Rd. chester, NY 10918 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P820034 | Original Filing | |
| S005 | 1996-12-12 | Normal 180 Day Track |
| S004 | 1992-06-08 | Normal 180 Day Track |
| S003 | 1992-05-14 | Normal 180 Day Track |
| S002 | 1985-02-04 | |
| S001 | 1985-01-09 |