UROLUME ENDOPROSTHESIS
FDA premarket approval P920023/S011 · decided 2000-02-09
Approval details
- PMA number
- P920023
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- UROLUME ENDOPROSTHESIS
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Applicant
- Boston Scientific Corp
- Date received
- 2000-02-04
- Decision date
- 2000-02-09
- Days to decision
- 5 days
- Decision code
- APPR
- Product code
- MES
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- Modification to the delivery tool handle.
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510(k) clearances by this applicant
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|---|---|---|
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| WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary (K152853) | Boston Scientific Corp | 2015-11-20 |
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| XXL Vascular Balloon Dilatation Catheter (K150303) | Boston Scientific Corp | 2015-06-15 |
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| EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679) | Boston Scientific Corp | 2015-05-29 |
| JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820) | Boston Scientific Corp | 2014-10-21 |