HDE
H990003: ARTIFICIAL BOWEL SPHINCTER PROSTHESIS
FDA Humanitarian Device Exemption · AMERICAN MEDICAL SYSTEMS, INC.
Key facts
| HDE number | H990003 |
|---|---|
| Trade name | ARTIFICIAL BOWEL SPHINCTER PROSTHESIS |
| Generic name | Implanted fecal incontinence device |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. |
| Product code | MIP |
| Approval date | Sep 20, 1999 |
| Docket number | 99M-4619 |
At a glance
- 1–9 Supplements
- May 23, 2000 Latest supplement decision
- Yes Summary of safety and probable benefit 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 HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: