Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | UROLUME(TM)ENDOURETHRAL WALLSTENT(R) PROSTHESIS |
Generic Name | STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT |
Applicant | Boston Scientific Corp. 100 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P920023 |
Supplement Number | S001 |
Date Received | 05/06/1996 |
Decision Date | 04/11/1997 |
Withdrawal Date
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04/11/2016 |
Product Code |
MER |
Docket Number | 98M-0050 |
Notice Date | 02/09/1998 |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |
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