PMA P920023S001

Device: UROLUME(TM)ENDOURETHRAL WALLSTENT(R) PROSTHESIS
Applicant: Boston Scientific Corp
PMA number: P920023
Supplement: S001
Product code: MER
Decision date: 1997-04-11
Generic name: STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
Approval order statement: APPROVAL FOR THE UROLUME(TM) ENDOURETHRAL PROSTHESIS FOR PROSTATIC OBSTRUCTION SECONDARY TO BENIGN PROSTATIC HYPERTROPHY(BPH). THIS DEVICE IS INTENDED TO RELIEVE PROSTATIC OBSTRUCTION SECONDARY TO BPH IN MEN AT LEAST 60 YRS OF AGE, OR MEN UNDER 60 YEARS OF AGE WHO ARE POOR SURGICAL CANDIDATES, AND WHOSE PROSTATES ARE AT LEAST 2.5CM IN LENGTH.

Current openFDA PMA Record

Device: UROLUME(TM)ENDOURETHRAL WALLSTENT(R) PROSTHESIS
Applicant: Boston Scientific Corp
PMA number: P920023
Supplement: S001
Product code: MER
Generic name: STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
Decision date: 1997-04-11
Decision code: APPR
Date received: 1996-05-06
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE UROLUME(TM) ENDOURETHRAL PROSTHESIS FOR PROSTATIC OBSTRUCTION SECONDARY TO BENIGN PROSTATIC HYPERTROPHY(BPH). THIS DEVICE IS INTENDED TO RELIEVE PROSTATIC OBSTRUCTION SECONDARY TO BPH IN MEN AT LEAST 60 YRS OF AGE, OR MEN UNDER 60 YEARS OF AGE WHO ARE POOR SURGICAL CANDIDATES, AND WHOSE PROSTATES ARE AT LEAST 2.5CM IN LENGTH.