PMA N970012S193
- Device
- AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone
- Applicant
- Boston Scientific Corp
- Product code
- JCW
- Decision date
- 2022-11-09
- Generic name
- Prosthesis, penis, inflatable
- Approval order statement
- Modifying the foreign material inspection of the cylinder front tip AMS 700 components.
Current openFDA PMA Record#
- Device
- AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S193
- Product code
- JCW
- Generic name
- Prosthesis, penis, inflatable
- Decision date
- 2022-11-09
- Decision code
- OK30
- Date received
- 2022-10-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifying the foreign material inspection of the cylinder front tip AMS 700 components.