- Device
- AMS 700 Inflatable Penile Prosthesis
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S186
- Product code
- JCW
- Generic name
- Prosthesis, penis, inflatable
- Decision date
- 2021-05-26
- Decision code
- OK30
- Date received
- 2021-04-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add an additional in-process pump inspection sequence to the existing functional pump test sequence used for 100% verification of momentary squeeze (MS) pumps