FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Prosthesis, Penis, Inflatable
PMA: N970012
·
Supplement: S211
·
Decision May 18, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Prosthesis, Penis, Inflatable
- Trade Name
- AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone
- PMA Number
- N970012
- Supplement Number
- S211
- 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
- May 18, 2026
- Date Received
- February 17, 2026
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for the design change to the TENACIO pump control valve.
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 |