PMA N970012S185
- Device
- AMS 700 Inflatable Penile Prosthesis
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S185
- Product code
- JCW
- Decision date
- 2021-03-16
- Generic name
- Prosthesis, penis, inflatable
- Approval order statement
- Manufacturing change to include the addition of an inspection of the Kink Resistant Tubing cylinder angle.
Current openFDA PMA Record#
- Device
- AMS 700 Inflatable Penile Prosthesis
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S185
- Product code
- JCW
- Generic name
- Prosthesis, penis, inflatable
- Decision date
- 2021-03-16
- Decision code
- OK30
- Date received
- 2021-02-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing change to include the addition of an inspection of the Kink Resistant Tubing cylinder angle.