PMA P920023S023
- Device
- Ams Urolume Endoprosthesis
- Applicant
- Boston Scientific Corp.
- PMA number
- P920023
- Supplement
- S023
- Decision date
- 2011-11-23
Current openFDA PMA Record
- Device
- AMS UROLUME ENDOPROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S023
- Product code
- MES
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Decision date
- 2011-11-23
- Decision code
- APPR
- Date received
- 2008-03-26
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR MODIFICATION OF THE DEVICE LABELING TO INCLUDE THE RESULTS OF POST APPROVAL STUDIES.