PMA N970012S203

Device: AMS 700™ Inflatable Penile Prosthesis without InhibiZone™
Applicant: Boston Scientific Corp
PMA number: N970012
Supplement: S203
Product code: JCW
Decision date: 2024-05-29
Classification: Gastroenterology, Urology
Generic name: Prosthesis, penis, inflatable
Approval order statement: a change to the supplier-provided adhesive formulation applied to Tyvek lids at the supplier. The Tyvek lids with the adhesive are supplied to BSC and used to seal the lids to plastic trays to create the sterile barrier

Current openFDA PMA Record#

Device: AMS 700™ Inflatable Penile Prosthesis without InhibiZone™
Applicant: Boston Scientific Corp
PMA number: N970012
Supplement: S203
Product code: JCW
Generic name: Prosthesis, penis, inflatable
Decision date: 2024-05-29
Decision code: OK30
Date received: 2024-05-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change to the supplier-provided adhesive formulation applied to Tyvek lids at the supplier. The Tyvek lids with the adhesive are supplied to BSC and used to seal the lids to plastic trays to create the sterile barrier