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.
| Device | REPRO-MED - THD ADDRESS CHANGE / MANU. FACILITY |
| Generic Name | Device, Testicular Hypothermia |
| Applicant | REPRO-MED SYSTEMS, INC. |
| Date Received | 1992-05-14 |
| Decision Date | 1993-04-28 |
| PMA | P820034 |
| Supplement | S003 |
| 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 |