FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Prosthesis, Penis, Inflatable
PMA: N970012
·
Supplement: S121
·
Decision Feb 10, 2017
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Prosthesis, Penis, Inflatable
- Trade Name
- AMBICOR INFLATABLE PENILE PROSTHESES
- PMA Number
- N970012
- Supplement Number
- S121
- 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
- February 10, 2017
- Date Received
- November 9, 2016
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for minor changes to dimensions and tolerances on the Ambicor device engineering drawings as part of ongoing remediation activities to align the engineering drawings with historical design intent and current manufacturing.
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 |