FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Prosthesis, Penis, Inflatable
PMA: N970012
·
Decision Nov 2, 1998
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Prosthesis, Penis, Inflatable
- Trade Name
- AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESES
- PMA Number
- N970012
- Device Class
- FDA Class 3
- Product Code
- JCW
- Generic Name
- Prosthesis, penis, inflatable
- Regulation Number
- 876.3350
- Medical Specialty
- Gastroenterology, Urology
- Advisory Committee
- Gastroenterology, Urology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 2, 1998
- Date Received
- December 22, 1997
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE AMS 700 SERIES INFLATABLE PENILE PROSTHESIS PRODUCT LINE. THIS DEVICE IS INDICATED FOR USE IN THE TREATMENT OF CHRONIC, ORGANIC, MALE ERECTILE DYSFUNCTION (IMPOTENCE).
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 |
|---|---|---|---|
| JCW | Prosthesis, Penis, Inflatable | FDA class 3 | Gastroenterology, Urology |