Identity
- Trade Name
- ANGELCHIK ANTI-REFLUX PROSTHESIS FDA PMA
- Generic Name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX FDA PMA
Identifiers
- PMA Number
- P790006 FDA PMA
- FDA Product Code
- LEI FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Gastroenterology, Urology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
- PMA Supplement
- S004 FDA PMA
The Angelchik Anti-Reflux Prosthesis is an implant designed for anti-gastroesophageal reflux. It is classified as a Class III device under the generic name Implant, Anti-Gastroesophageal Reflux.
This prosthesis received FDA PMA approval (P790006) on July 2, 1984, following submission received May 3, 1984. It is manufactured by Allergan, Inc. in Santa Barbara, CA, and is intended for use in gastroenterology and urology applications as indicated by the GU advisory committee.
Frequently asked questions
What is the Angelchik Anti-Reflux Prosthesis used for?
The Angelchik Anti-Reflux Prosthesis is an implant designed for anti-gastroesophageal reflux, as defined by its generic name and device classification. It is intended to address gastroesophageal reflux through surgical implantation.
Who manufactures the Angelchik Anti-Reflux Prosthesis and where is it made?
The Angelchik Anti-Reflux Prosthesis is manufactured by Allergan, Inc., with the manufacturer's address listed as 5540 Ekwill St., Santa Barbara, CA 93111, based on the provided specifications.
What regulatory authorization does the Angelchik Anti-Reflux Prosthesis have?
The device has FDA PMA (Premarket Approval) authorization, with PMA number P790006, approved on July 2, 1984, after being received on May 3, 1984. This is the only authorization explicitly stated in the data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P790006 | Class III | Active |
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Manufacturer
- Manufacturer
- Allergan, Inc.
Sources (1)
- FDA PMA P790006 24 fields · synced Sep 18, 2026