PMA
P790006: ANGELCHIK ANTI-REFLUX PROSTHESIS
FDA PMA · IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX · Allergan, Inc.
Key facts
| PMA number | P790006 |
|---|---|
| Trade name | ANGELCHIK ANTI-REFLUX PROSTHESIS |
| Generic name | IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX |
| Applicant | Allergan, Inc. |
| Owner/operator | AbbVie, Inc. |
| Product code | LEI |
| Approval date | Oct 19, 1979 |
| Notice date | Jul 18, 1980 |
| Establishment registration | 2011068 |
| FEI number | 2011068 |
At a glance
- 1–9 Supplements
- Oct 25, 1990 Latest supplement decision
- Yes Withdrawn
- No 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: