PMA P920023S005

Device: UROLUME(TM)ENDOPROSTHESIS
Applicant: Boston Scientific Corp
PMA number: P920023
Supplement: S005
Product code: MER
Decision date: 1998-07-07
Generic name: STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
Approval order statement: Approval to add a new contraindication regarding fracture distraction defects of the posterior urethra to the labeling of the UroLume(R) stricture application. Your supplement also requested approval to modify the labeling of the stricture and BPH applications to clarify that the UroLume(R) is not intended for temporary use.

Current openFDA PMA Record

Device: UROLUME(TM)ENDOPROSTHESIS
Applicant: Boston Scientific Corp
PMA number: P920023
Supplement: S005
Product code: MER
Generic name: STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
Decision date: 1998-07-07
Decision code: APPR
Date received: 1998-06-25
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to add a new contraindication regarding fracture distraction defects of the posterior urethra to the labeling of the UroLume(R) stricture application. Your supplement also requested approval to modify the labeling of the stricture and BPH applications to clarify that the UroLume(R) is not intended for temporary use.