PMA
P820034: REPRO-MED - THD
FDA PMA · DEVICE, TESTICULAR HYPOTHERMIA · Repro-Med Systems, Inc.
Key facts
| PMA number | P820034 |
|---|---|
| Trade name | REPRO-MED - THD |
| Generic name | DEVICE, TESTICULAR HYPOTHERMIA |
| Applicant | Repro-Med Systems, Inc. |
| Owner/operator | MED SYSTEMS |
| Product code | LOA |
| Approval date | Dec 26, 1984 |
| Docket number | 85M-0007 |
| Notice date | Jan 25, 1985 |
| Establishment registration | 2022691 |
| FEI number | 2022691 |
At a glance
- 1–9 Supplements
- Jan 14, 1997 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: