PMA supplement
P060010 S013: The Spanner Temporary Prostatic Stent
FDA PMA supplement · Panel Track · Srs Medical
Key facts
| Original PMA | P060010 |
|---|---|
| Supplement number | S013 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | The Spanner Temporary Prostatic Stent |
| Generic name | Stent, urethral, prostatic, semi-permanent |
| Applicant | Srs Medical |
| Product code | NZC |
| Received date | Jun 22, 2020 |
| Decision date | Oct 7, 2022 |
| Docket number | 22M-2543 |
| Notice date | Oct 17, 2022 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: