PMA supplement
P000006 S001: ALPHA I INFLATABLE PENILE PROSTHESIS
FDA PMA supplement · Normal 180 Day Track · Coloplast Corp.
Key facts
| Original PMA | P000006 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | ALPHA I INFLATABLE PENILE PROSTHESIS |
| Generic name | Device, impotence, mechanical/hydraulic |
| Applicant | Coloplast Corp. |
| Product code | FHW |
| Received date | May 17, 2001 |
| Decision date | Jun 14, 2002 |
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: