- Device
- AMS 700 Implantable Penile Prosthesis with and without Inhibizone Treatment
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S183
- Product code
- JCW
- Generic name
- Prosthesis, penis, inflatable
- Decision date
- 2020-10-30
- Decision code
- OK30
- Date received
- 2020-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the manufacturing process for the outer and inner Tyvek packaging pre-printed tray lids components.