PMA supplement
P990002 S002: FEMSOFT URETHRAL INSERT
FDA PMA supplement · Normal 180 Day Track No User Fee · Rochester Medical Corp.
Key facts
| Original PMA | P990002 |
|---|---|
| Supplement number | S002 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | FEMSOFT URETHRAL INSERT |
| Generic name | Transurethral occlusion insert, urinary incontinence-control, female |
| Applicant | Rochester Medical Corp. |
| Product code | OCK |
| Received date | Dec 26, 2012 |
| Decision date | Mar 21, 2013 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: