- Device
- AMS 700 Inflatable Penile Prosthesis with and without Inhibizone Treatment
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S181
- Product code
- JCW
- Generic name
- Prosthesis, penis, inflatable
- Decision date
- 2020-09-09
- Decision code
- OK30
- Date received
- 2020-08-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing site change to the St. Paul, Minnesota facility for the extrusion process for the cylinder components.