UROLUME ENDOURETHRAL PROSTHESIS
FDA premarket approval P920023/S017 · decided 2003-11-14
Approval details
- PMA number
- P920023
- Supplement
- S017
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- UROLUME ENDOURETHRAL PROSTHESIS
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Applicant
- Boston Scientific Corp
- Date received
- 2003-10-16
- Decision date
- 2003-11-14
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MES
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- APPROVAL FOR CHANGES TO THE LABELING REGARDING THE DEPLOYMENT OF THE DEVICE AND WITHDRAWAL OF THE DELIVERY INSTRUMENT.
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