PMA N970012S192

Device: AMS 700™ Inflatable Penile Prosthesis (IPP) with and without lnhibiZone ™ Treatment
Applicant: Boston Scientific Corp
PMA number: N970012
Supplement: S192
Product code: JCW
Decision date: 2022-09-01
Generic name: Prosthesis, penis, inflatable
Approval order statement: Process change to the Global Labeling System version 3.0 software and infrastructure from the current Minnetonka Labeling System.

Current openFDA PMA Record#

Device: AMS 700™ Inflatable Penile Prosthesis (IPP) with and without lnhibiZone ™ Treatment
Applicant: Boston Scientific Corp
PMA number: N970012
Supplement: S192
Product code: JCW
Generic name: Prosthesis, penis, inflatable
Decision date: 2022-09-01
Decision code: OK30
Date received: 2022-08-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Process change to the Global Labeling System version 3.0 software and infrastructure from the current Minnetonka Labeling System.