- Device
- UROLUME(TM)ENDOURETHRAL WALLSTENT(R) PROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S002
- Product code
- MER
- Generic name
- STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
- Decision date
- 1996-09-27
- Decision code
- APPR
- Date received
- 1996-09-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO INCREASE THE NUMBER OF INVESTIGATIONAL SITES FROM 7 TO 8 FOR THE "POST APPROVAL STUDY FOR THE UROLUME ENDOPROSTHESIS FOR TREATING RECURRENT BULBAR URETHRAL STRICTURE DISEASE