PMA supplement
N970012 S189: AMS 700 Inflatable Penile Prosthesis with and without InhibiZone
FDA PMA supplement · 30-Day Notice · Boston Scientific Corp
Key facts
| Original PMA | N970012 |
|---|---|
| Supplement number | S189 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | AMS 700 Inflatable Penile Prosthesis with and without InhibiZone |
| Generic name | Prosthesis, penis, inflatable |
| Applicant | Boston Scientific Corp |
| Product code | JCW |
| Received date | Aug 24, 2021 |
| Decision date | Sep 8, 2021 |
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: