- Device
- AMS 700™ Inflatable Penile Prosthesis, AMS 700™ Inflatable Penile Prosthesis with InhibiZone™
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S195
- Product code
- JCW
- Generic name
- Prosthesis, penis, inflatable
- Decision date
- 2023-02-10
- Decision code
- OK30
- Date received
- 2023-01-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Supplier change of the traction suture due to the original supplier leaving the medical market.