PMA P920023S014

Device: UROLUME(R) ENDOPROSTHESIS
Applicant: Boston Scientific Corp
PMA number: P920023
Supplement: S014
Product code: MES
Decision date: 2001-06-07
Classification: Gastroenterology, Urology
Generic name: STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
Approval order statement: APPROVAL FOR A 1.5 CM STENT LENGTH, A MODIFICATION OF THE BENIGN PROSTATIC HYPERTROPHY (BPH) INDICATION, AND CORRECTION OF DELIVERY TOOL LABELING. THE DEVICE, AS MIDIFIED, WILL BE MARKETED UNDER THE TRADE NAME UROLUME(R) ENDOPROSTHESIS. THE BPH INDICATION OF THE UROLUME(R) ENDOPROSTHESIS WILL BE MODIFIED AS FOLLOWS: THE DEVICE IS INTENDED TO RELIEVE PROSTATIC OBSTRUCTION SECONDARY TO BPH IN MEN AT LEAST 60 YEARS OF AGE, OR MEN UNDER 60 YEARS OF AGE WHO ARE POOR SURGICAL CANDIDATES, AND WHOSE PROSTATES ARE AT LEAST 2.0 CM IN LENGTH.

Current openFDA PMA Record#

Device: UROLUME(R) ENDOPROSTHESIS
Applicant: Boston Scientific Corp
PMA number: P920023
Supplement: S014
Product code: MES
Generic name: STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
Decision date: 2001-06-07
Decision code: APPR
Date received: 2000-12-18
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A 1.5 CM STENT LENGTH, A MODIFICATION OF THE BENIGN PROSTATIC HYPERTROPHY (BPH) INDICATION, AND CORRECTION OF DELIVERY TOOL LABELING. THE DEVICE, AS MIDIFIED, WILL BE MARKETED UNDER THE TRADE NAME UROLUME(R) ENDOPROSTHESIS. THE BPH INDICATION OF THE UROLUME(R) ENDOPROSTHESIS WILL BE MODIFIED AS FOLLOWS: THE DEVICE IS INTENDED TO RELIEVE PROSTATIC OBSTRUCTION SECONDARY TO BPH IN MEN AT LEAST 60 YEARS OF AGE, OR MEN UNDER 60 YEARS OF AGE WHO ARE POOR SURGICAL CANDIDATES, AND WHOSE PROSTATES ARE AT LEAST 2.0 CM IN LENGTH.