PMA P920023S022

Device: AMS UROLUME ENDOPROSTHESIS
Applicant: Boston Scientific Corp
PMA number: P920023
Supplement: S022
Product code: MES
Decision date: 2007-08-08
Classification: Gastroenterology, Urology
Generic name: STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
Approval order statement: APPROVAL FOR A LABELING CHANGE TO ADD HYPOSPADIAS AS A PRECAUTION WHEN USING THE UROLUME FOR THE TREATMENT OF RECURRENT BULBAR URETHRAL STRICTURES.

Current openFDA PMA Record#

Device: AMS UROLUME ENDOPROSTHESIS
Applicant: Boston Scientific Corp
PMA number: P920023
Supplement: S022
Product code: MES
Generic name: STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
Decision date: 2007-08-08
Decision code: APPR
Date received: 2007-07-19
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A LABELING CHANGE TO ADD HYPOSPADIAS AS A PRECAUTION WHEN USING THE UROLUME FOR THE TREATMENT OF RECURRENT BULBAR URETHRAL STRICTURES.