PMA N970012S200
- Device
- AMS 700 ™ Implantable Penile Prosthesis without lnhibiZone™
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S200
- Product code
- JCW
- Decision date
- 2023-11-22
- Classification
- Gastroenterology, Urology
- Generic name
- Prosthesis, penis, inflatable
- Approval order statement
- a change in the adhesive used during the sealing of the sterile barrier system
Current openFDA PMA Record#
- Device
- AMS 700 ™ Implantable Penile Prosthesis without lnhibiZone™
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S200
- Product code
- JCW
- Generic name
- Prosthesis, penis, inflatable
- Decision date
- 2023-11-22
- Decision code
- OK30
- Date received
- 2023-11-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change in the adhesive used during the sealing of the sterile barrier system