- Device
- UROLUME ENDOURETHRAL PROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S017
- Product code
- MES
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Decision date
- 2003-11-14
- Decision code
- APPR
- Date received
- 2003-10-16
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE LABELING REGARDING THE DEPLOYMENT OF THE DEVICE AND WITHDRAWAL OF THE DELIVERY INSTRUMENT.