FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Implant, Anti-Gastroesophageal Reflux
PMA: P790006
·
Supplement: S002
·
Decision May 14, 1981
Classifications
1
FEI Numbers
2
Registration Numbers
2
Basic Information
- Device Name
- Implant, Anti-Gastroesophageal Reflux
- Trade Name
- ANGEL CHIK ANTI-REFLUX PROSTHESIS
- PMA Number
- P790006
- Supplement Number
- S002
- Device Class
- FDA Class 3
- Product Code
- LEI
- Generic Name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Medical Specialty
- Unknown
- Advisory Committee
- Gastroenterology, Urology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- May 14, 1981
- Date Received
- April 2, 1981
- 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 |