FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Implant, Anti-Gastroesophageal Reflux
PMA: P790006
·
Decision Oct 19, 1979
Classifications
1
FEI Numbers
2
Registration Numbers
2
Basic Information
- Device Name
- Implant, Anti-Gastroesophageal Reflux
- Trade Name
- ANGELCHIK ANTI-REFLUX PROSTHESIS
- PMA Number
- P790006
- Device Class
- FDA Class 3
- Product Code
- LEI
- Generic Name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Medical Specialty
- Unknown
- Advisory Committee
- Gastroenterology, Urology
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- October 19, 1979
- Date Received
- February 5, 1979
- Expedited Review
- N
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LEI | Implant, Anti-Gastroesophageal Reflux | FDA class 3 | Unknown |