UROLUME ENDOURETHRAL PROSTHESIS FOR PROSTATIC OBSTRUCTION SECONDARY TO BENIGN PROSTATIC HYPERTROPHY
FDA premarket approval P920023/S015 · decided 2004-07-22
Approval details
- PMA number
- P920023
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- UROLUME ENDOURETHRAL PROSTHESIS FOR PROSTATIC OBSTRUCTION SECONDARY TO BENIGN PROSTATIC HYPERTROPHY
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Applicant
- Boston Scientific Corp
- Date received
- 2002-07-01
- Decision date
- 2004-07-22
- Days to decision
- 752 days
- Decision code
- APPR
- Product code
- MES
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- APPROVAL TO CONCLUDE THE BENIGN PROSTATIC HYPERTROPHY PORTION OF THE UROLUME POST-APPROVAL STUDY AND TO INCLUDE THE PROBABILITY OF EXPLANT DUE TO TISSUE RESPONSE AT 10 YEARS IN THE LABELING.
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