PMA P920023S003
- Device
- UROLUME(TM)ENDOURETHRAL WALLSTENT(R) PROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S003
- Product code
- MER
- Decision date
- 1997-04-29
- Generic name
- STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
- Approval order statement
- APPROVAL FOR CHANGES TO THE POST-APPROVAL STUDIES.
Current openFDA PMA Record
- Device
- UROLUME(TM)ENDOURETHRAL WALLSTENT(R) PROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S003
- Product code
- MER
- Generic name
- STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
- Decision date
- 1997-04-29
- Decision code
- APPR
- Date received
- 1997-04-25
- Supplement type
- Real-Time Process
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL FOR CHANGES TO THE POST-APPROVAL STUDIES.