PMA N970012S207
- Device
- AMS 700™ Inflatable Penile Prosthesis without InhibiZone™
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S207
- Product code
- JCW
- Decision date
- 2025-05-28
- Classification
- Gastroenterology, Urology
- Generic name
- Prosthesis, penis, inflatable
- Approval order statement
- approval for an alternate packaging tray supplier
Current openFDA PMA Record#
- Device
- AMS 700™ Inflatable Penile Prosthesis without InhibiZone™
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S207
- Product code
- JCW
- Generic name
- Prosthesis, penis, inflatable
- Decision date
- 2025-05-28
- Decision code
- OK30
- Date received
- 2025-05-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for an alternate packaging tray supplier