Urolume Endoprosthesis

FDA premarket approval P920023 · Stent, Urethral, Bulbous, Permanent or Semi-Permanent

PMA numberP920023

Approval

Applicant
Boston Scientific Corp
Received
May 12, 1992
Decision date
May 6, 1996 (APWD)
Supplements
30, latest August 2, 2012
Product code
MES – Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

Official FDA PMA record

Approval order statement

APPROVAL FOR THE UROLUME ENDORETHRAL PROSTHESIS FOR URETHRAL STRICTURES (REFERRED TO AS UROLUME HEREINAFTER)