PMA N970012S212
- Device
- AMS 700™ Inflatable Penile Prosthesis (IPP)
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S212
- Product code
- JCW
- Decision date
- 2026-09-14
- Classification
- Gastroenterology, Urology
- Generic name
- Prosthesis, penis, inflatable
- Approval order statement
- use of new kink resistant endcaps and process changes to accommodate those endcaps
Current openFDA PMA Record#
- Device
- AMS 700™ Inflatable Penile Prosthesis (IPP)
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S212
- Product code
- JCW
- Generic name
- Prosthesis, penis, inflatable
- Decision date
- 2026-09-14
- Decision code
- OK30
- Date received
- 2026-09-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- use of new kink resistant endcaps and process changes to accommodate those endcaps