UROLUME(R) ENDOPROSTHESIS

FDA premarket approval P920023/S014 · decided 2001-06-07

Approval details

PMA number

P920023

Supplement

S014

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

UROLUME(R) ENDOPROSTHESIS

Generic name

STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT

Applicant

Boston Scientific Corp

Date received

2000-12-18

Decision date

2001-06-07

Days to decision

171 days

Decision code

APPR

Product code

MES

Advisory committee

Gastroenterology, Urology

Expedited review

No

Location

Marlboro, MA

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 PRO

510(k) clearances by this applicant