FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Prosthesis, Penis, Inflatable
PMA: N970012
·
Supplement: S210
·
Decision Oct 2, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
Research PMA N970012 in seconds
The Research Assistant summarizes PMA approval history, supplements and related safety signals — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Prosthesis, Penis, Inflatable
- Trade Name
- AMS 700 Inflatable Penile Prosthesis with and without InhibiZone
- PMA Number
- N970012
- Supplement Number
- S210
- 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
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- October 2, 2025
- Date Received
- September 30, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
changes for the pump to kink resistant tubing bonding process preparation and equipment for TENACIO Pump components at Boston Scientific Corporation (BSC) St. Paul
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 |