PMA supplement
P060010 S003: SPANNER TEMPORARY PROSTATIC STENT WITH DISTAL CURVE DESIGN CHANGE
FDA PMA supplement · Real-Time Process · Srs Medical
Key facts
| Original PMA | P060010 |
|---|---|
| Supplement number | S003 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | SPANNER TEMPORARY PROSTATIC STENT WITH DISTAL CURVE DESIGN CHANGE |
| Generic name | Stent, urethral, prostatic, semi-permanent |
| Applicant | Srs Medical |
| Product code | NZC |
| Received date | Jan 12, 2009 |
| Decision date | Mar 10, 2009 |
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: