PMA P920023S028
- Device
- UROLUME ENDOPROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S028
- Product code
- MES
- Decision date
- 2010-09-23
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Approval order statement
- APPROVAL FOR A MODIFICATION OF SPECIFICATIONS OF THE RADIUS AND LOCATION OF THE BUMP ON THE END OF THE UROLUME ENDOPROSTHESIS OUTER TUBE.
Current openFDA PMA Record#
- Device
- UROLUME ENDOPROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S028
- Product code
- MES
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Decision date
- 2010-09-23
- Decision code
- APPR
- Date received
- 2010-09-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MODIFICATION OF SPECIFICATIONS OF THE RADIUS AND LOCATION OF THE BUMP ON THE END OF THE UROLUME ENDOPROSTHESIS OUTER TUBE.