PMA N970012S189
- Device
- AMS 700 Inflatable Penile Prosthesis with and without InhibiZone
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S189
- Product code
- JCW
- Decision date
- 2021-09-08
- Generic name
- Prosthesis, penis, inflatable
- Approval order statement
- Changes to the valve block molding equipment and process for cavities 9 and 10.
Current openFDA PMA Record#
- Device
- AMS 700 Inflatable Penile Prosthesis with and without InhibiZone
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S189
- Product code
- JCW
- Generic name
- Prosthesis, penis, inflatable
- Decision date
- 2021-09-08
- Decision code
- OK30
- Date received
- 2021-08-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the valve block molding equipment and process for cavities 9 and 10.