PMA P920023S013
- Device
- UROLUME ENDOPROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S013
- Product code
- MES
- Decision date
- 2001-05-01
- Classification
- Gastroenterology, Urology
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Approval order statement
- APPROVAL FOR AN AUTOMATED MANUFACTURING PROCESS TO CUT STENTS TO LENTH.
Current openFDA PMA Record#
- Device
- UROLUME ENDOPROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S013
- Product code
- MES
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Decision date
- 2001-05-01
- Decision code
- APPR
- Date received
- 2000-12-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN AUTOMATED MANUFACTURING PROCESS TO CUT STENTS TO LENTH.