PMA
P990002: FEMSOFT URETHRAL INSERT
FDA PMA · Transurethral occlusion insert, urinary incontinence-control, female · Rochester Medical Corp.
Key facts
| PMA number | P990002 |
|---|---|
| Trade name | FEMSOFT URETHRAL INSERT |
| Generic name | Transurethral occlusion insert, urinary incontinence-control, female |
| Applicant | Rochester Medical Corp. |
| Product code | OCK |
| Approval date | Sep 30, 1999 |
| Docket number | 99M-4330 |
| Notice date | Oct 15, 1999 |
| FEI number | 2130787 |
At a glance
- 1–9 Supplements
- Mar 21, 2013 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: