FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Prosthesis, Penis, Inflatable
PMA: N970012
·
Supplement: S151
·
Decision Jan 15, 2019
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Prosthesis, Penis, Inflatable
- Trade Name
- AMS Ambicor Inflatable Penile Prosthesis (IPP)
- PMA Number
- N970012
- Supplement Number
- S151
- 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
- January 15, 2019
- Date Received
- October 15, 2018
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for labeling and minor packaging modifications.
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 |