- Device
- AMS 700 Inflatable Penile Prosthesis (with InhibiZone)
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S202
- Product code
- JCW
- Generic name
- Prosthesis, penis, inflatable
- Decision date
- 2024-05-23
- Decision code
- APPR
- Date received
- 2024-03-29
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the batch release and stability evaluation for AMS 700™ Inflatable Penile Prosthesis and AMS 800™ Artificial Urinary Sphincter with lnhibiZone products