PMA
P000053: AMS SPHINCTER 800 URINARY CONTROL SYSTEM
FDA PMA · Device, incontinence, mechanical/hydraulic · Boston Scientific Corp
Key facts
| PMA number | P000053 |
|---|---|
| Trade name | AMS SPHINCTER 800 URINARY CONTROL SYSTEM |
| Generic name | Device, incontinence, mechanical/hydraulic |
| Applicant | Boston Scientific Corp |
| Owner/operator | Boston Scientific Corporation |
| Product code | EZY |
| Approval date | Jun 14, 2001 |
| Docket number | 01M-0579 |
| Notice date | Dec 21, 2001 |
| Establishment registration | 3005099803 |
| FEI number | 3005099803 |
At a glance
- 100–999 Supplements
- Sep 14, 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- No Withdrawn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: