PMA
P960020: RELIANCE URINARY CONTROL INSERT AND SIZING DEVICE
FDA PMA · Transurethral occlusion insert, urinary incontinence-control, female · Uromed Corp.
Key facts
| PMA number | P960020 |
|---|---|
| Trade name | RELIANCE URINARY CONTROL INSERT AND SIZING DEVICE |
| Generic name | Transurethral occlusion insert, urinary incontinence-control, female |
| Applicant | Uromed Corp. |
| Product code | OCK |
| Approval date | Aug 16, 1996 |
| Docket number | 96M-0447 |
| Notice date | Dec 2, 1996 |
At a glance
- 1–9 Supplements
- Apr 1, 1999 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- No Withdrawn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: