- Device
- AMS 700™ Inflatable Penile Prosthesis with and without InhibiZone™
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S210
- Product code
- JCW
- Generic name
- Prosthesis, penis, inflatable
- Decision date
- 2025-10-02
- Decision code
- OK30
- Date received
- 2025-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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