PMA P920023S025

Device: AMS UROLUME ENDOPROSTHESIS
Applicant: Boston Scientific Corp
PMA number: P920023
Supplement: S025
Product code: MES
Decision date: 2008-06-27
Classification: Gastroenterology, Urology
Generic name: STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
Approval order statement: CHANGE IN VENDOR FOR THE PLASTIC INJECTION MOLDED PARTS OF THE DEVICE AND THE ADDITION OF AN IN-PROCESS PULL-OUT TEST TO THE CURRENT MANUFACTURING PROCEDURE.

Current openFDA PMA Record#

Device: AMS UROLUME ENDOPROSTHESIS
Applicant: Boston Scientific Corp
PMA number: P920023
Supplement: S025
Product code: MES
Generic name: STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
Decision date: 2008-06-27
Decision code: OK30
Date received: 2008-06-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN VENDOR FOR THE PLASTIC INJECTION MOLDED PARTS OF THE DEVICE AND THE ADDITION OF AN IN-PROCESS PULL-OUT TEST TO THE CURRENT MANUFACTURING PROCEDURE.