PMA N970012S201

Device: AMS 700™ Inflatable Penile Prosthesis (IPP
Applicant: Boston Scientific Corp
PMA number: N970012
Supplement: S201
Product code: JCW
Decision date: 2023-12-11
Classification: Gastroenterology, Urology
Generic name: Prosthesis, penis, inflatable
Approval order statement: a change to the process and equipment for mixing the silicone elastomer material used for extrusion of the kink resistant tubing (KRT) component of the AMS 700 IPP and AMS 800 AUS devices at Boston Scientific Corporation (BSC) St. Paul

Current openFDA PMA Record#

Device: AMS 700™ Inflatable Penile Prosthesis (IPP
Applicant: Boston Scientific Corp
PMA number: N970012
Supplement: S201
Product code: JCW
Generic name: Prosthesis, penis, inflatable
Decision date: 2023-12-11
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 to the process and equipment for mixing the silicone elastomer material used for extrusion of the kink resistant tubing (KRT) component of the AMS 700 IPP and AMS 800 AUS devices at Boston Scientific Corporation (BSC) St. Paul