PMA
P060010: THE SPANNER TEMPORARY PROSTATIC STENT
FDA PMA · Stent, urethral, prostatic, semi-permanent · Srs Medical
Key facts
| PMA number | P060010 |
|---|---|
| Trade name | THE SPANNER TEMPORARY PROSTATIC STENT |
| Generic name | Stent, urethral, prostatic, semi-permanent |
| Applicant | Srs Medical |
| Owner/operator | MENICON CO. LTD. |
| Product code | NZC |
| Approval date | Dec 14, 2006 |
| Docket number | 06M-0529 |
| Notice date | Dec 26, 2006 |
| Establishment registration | 3003515967 |
| FEI number | 3003515967 |
At a glance
- 10–99 Supplements
- Oct 7, 2022 Latest supplement decision
- No Withdrawn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: