- Device
- AMS 700 Inflatable Penile Prosthesis and AMS 700 Inflatable Penile Prosthesis with InhibiZone Treatment
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S180
- Product code
- JCW
- Generic name
- Prosthesis, penis, inflatable
- Decision date
- 2020-09-04
- Decision code
- OK30
- Date received
- 2020-08-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a new Kink Resistant Tubing (KRT) Fabrication Machine System to the KRT Production Line at the Boston Scientific St. Paul, Minnesota facility.