PMA
P000006: TITAN INFLATABLE PENILE PROSTHESIS
FDA PMA · Device, impotence, mechanical/hydraulic · Coloplast Corp.
Key facts
| PMA number | P000006 |
|---|---|
| Trade name | TITAN INFLATABLE PENILE PROSTHESIS |
| Generic name | Device, impotence, mechanical/hydraulic |
| Applicant | Coloplast Corp. |
| Owner/operator | Coloplast Corp. |
| Product code | FHW |
| Approval date | Jul 14, 2000 |
| Docket number | 00M-1415 |
| Notice date | Jul 25, 2000 |
| Establishment registration | 2125050 |
| FEI number | 2125050 |
At a glance
- 10–99 Supplements
- Aug 13, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: