PMA N970012
- Device
- AMS 700™ Inflatable Penile Prosthesis (IPP) with and without InhibiZone™
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S194
- Product code
- JCW
- Decision date
- 2026-05-18
- Generic name
- Prosthesis, penis, inflatable
- Approval order statement
- Approval for the design change to the TENACIO pump control valve.
Current openFDA PMA Record#
- Device
- AMS 700™ Inflatable Penile Prosthesis (IPP) with and without InhibiZone™
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S211
- Product code
- JCW
- Generic name
- Prosthesis, penis, inflatable
- Decision date
- 2026-05-18
- Decision code
- APPR
- Date received
- 2026-02-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the design change to the TENACIO pump control valve.