- Device
- AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without Inhibizone Treatment
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S178
- Product code
- JCW
- Generic name
- Prosthesis, penis, inflatable
- Decision date
- 2020-06-16
- Decision code
- OK30
- Date received
- 2020-05-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a new lid printing machine for the AMS 700 Inflatable Penile Prosthesis (IPP), Ambicor IPP, and AMS 800 AUS (Urinary Control System).