PMA N970012S209

Device: AMS 700 Inflatable Penile Prosthesis (IPP)
Applicant: Boston Scientific Corp
PMA number: N970012
Supplement: S209
Product code: JCW
Decision date: 2025-07-14
Classification: Gastroenterology, Urology
Generic name: Prosthesis, penis, inflatable
Approval order statement: changes to update manufacturing instructions to ensure proper component seating prior to tray sealing and updates to the visual packaging inspection process

Current openFDA PMA Record#

Device: AMS 700 Inflatable Penile Prosthesis (IPP)
Applicant: Boston Scientific Corp
PMA number: N970012
Supplement: S209
Product code: JCW
Generic name: Prosthesis, penis, inflatable
Decision date: 2025-07-14
Decision code: OK30
Date received: 2025-06-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: changes to update manufacturing instructions to ensure proper component seating prior to tray sealing and updates to the visual packaging inspection process