PMA P920023S016
- Device
- UROLUME ENDOPROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S016
- Product code
- MES
- Decision date
- 2003-08-08
- Classification
- Gastroenterology, Urology
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Approval order statement
- APPROVAL FOR ADDITIONAL DETAILED INSTRUCTIONS FOR PROSTHESIS REMOVAL AFTER UROTHELIAL COVERAGE.
Current openFDA PMA Record#
- Device
- UROLUME ENDOPROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S016
- Product code
- MES
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Decision date
- 2003-08-08
- Decision code
- APPR
- Date received
- 2003-07-11
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR ADDITIONAL DETAILED INSTRUCTIONS FOR PROSTHESIS REMOVAL AFTER UROTHELIAL COVERAGE.