PMA P920023S006
- Device
- UROLUME ENDOPROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S006
- Product code
- MER
- Decision date
- 1998-10-02
- Generic name
- STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
- Approval order statement
- Approval for the addition of a warning to the device labeling to reflect an unexpected adverse event.
Current openFDA PMA Record#
- Device
- UROLUME ENDOPROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S006
- Product code
- MER
- Generic name
- STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
- Decision date
- 1998-10-02
- Decision code
- APPR
- Date received
- 1998-09-24
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the addition of a warning to the device labeling to reflect an unexpected adverse event.