PMA
P010020: AMS ACTICON NEOSPHINCTER
FDA PMA · Implanted fecal incontinence device · Boston Scientific Corp
Key facts
| PMA number | P010020 |
|---|---|
| Trade name | AMS ACTICON NEOSPHINCTER |
| Generic name | Implanted fecal incontinence device |
| Applicant | Boston Scientific Corp |
| Owner/operator | Boston Scientific Corporation |
| Product code | MIP |
| Approval date | Dec 18, 2001 |
| Docket number | 01M-0581 |
| Notice date | Dec 26, 2001 |
| Establishment registration | 2124215 |
| FEI number | 2124215 |
At a glance
- 10–99 Supplements
- Feb 4, 2016 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: