PMA supplement
P010020 S017: ACTICON NEOSPHINTER
FDA PMA supplement · Normal 180 Day Track · Boston Scientific Corp
Key facts
| Original PMA | P010020 |
|---|---|
| Supplement number | S017 |
| Supplement type | Normal 180 Day Track |
| Trade name | ACTICON NEOSPHINTER |
| Generic name | Implanted fecal incontinence device |
| Applicant | Boston Scientific Corp |
| Product code | MIP |
| Received date | Nov 15, 2010 |
| Decision date | May 7, 2012 |
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: