UROLUME ENDOPROSTHESIS DELIVERY TOOL
FDA premarket approval P920023/S008 · decided 1999-04-13
Approval details
- PMA number
- P920023
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- UROLUME ENDOPROSTHESIS DELIVERY TOOL
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Applicant
- Boston Scientific Corp
- Date received
- 1999-03-09
- Decision date
- 1999-04-13
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- MES
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- Approval for a windowless version of the UroLume(R) Endoprosthesis delivery tool.
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