- Device
- AMS 700™ Inflatable Penile Prosthesis, AMS 700™ Inflatable Penile Prosthesis with InhibiZone™
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S190
- Product code
- JCW
- Generic name
- Prosthesis, penis, inflatable
- Decision date
- 2022-04-01
- Decision code
- OK30
- Date received
- 2022-03-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Process change to the water bath monitoring requirements for assembly of the AMS 700 IPP and AMS 800.