PMA N970012S199
- Device
- AMS 700™ Inflatable Penile Prosthesis
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S199
- Product code
- JCW
- Decision date
- 2023-09-15
- Classification
- Gastroenterology, Urology
- Generic name
- Prosthesis, penis, inflatable
- Approval order statement
- Changes to visual inspection requirements only for the Rear Tip Extenders (RTE) for the AMS 700 CXR cylinder models.
Current openFDA PMA Record#
- Device
- AMS 700™ Inflatable Penile Prosthesis
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S199
- Product code
- JCW
- Generic name
- Prosthesis, penis, inflatable
- Decision date
- 2023-09-15
- Decision code
- OK30
- Date received
- 2023-08-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to visual inspection requirements only for the Rear Tip Extenders (RTE) for the AMS 700 CXR cylinder models.