UROLUME(TM)ENDOPROSTHESIS
FDA premarket approval P920023/S005 · decided 1998-07-07
Approval details
- PMA number
- P920023
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- UROLUME(TM)ENDOPROSTHESIS
- Generic name
- STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
- Applicant
- Boston Scientific Corp
- Date received
- 1998-06-25
- Decision date
- 1998-07-07
- Days to decision
- 12 days
- Decision code
- APPR
- Product code
- MER
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- Approval to add a new contraindication regarding fracture distraction defects of the posterior urethra to the labeling of the UroLume(R) stricture application. Your supplement also requested approval to modify the labeling of the stricture and BPH applications to clarify that the UroLume(R) is not intended for temporary use.
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