- Device
- AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S204
- Product code
- JCW
- Generic name
- Prosthesis, penis, inflatable
- Decision date
- 2024-05-30
- Decision code
- OK30
- Date received
- 2024-05-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change of visual inspection of the TENACIO pump with a borescope. This new process incorporates a new Go/No-go fixture to address a new visual inspection