UROLUME(TM)ENDOURETHRAL WALLSTENT(R) PROSTHESIS
FDA premarket approval P920023/S001 · decided 1997-04-11
Approval details
- PMA number
- P920023
- Supplement
- S001
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- UROLUME(TM)ENDOURETHRAL WALLSTENT(R) PROSTHESIS
- Generic name
- STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
- Applicant
- Boston Scientific Corp
- Date received
- 1996-05-06
- Decision date
- 1997-04-11
- Days to decision
- 340 days
- Decision code
- APPR
- Product code
- MER
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- 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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