PMA P920023S018

Device: UROLUME ENDOPROSTHESIS
Applicant: Boston Scientific Corp
PMA number: P920023
Supplement: S018
Product code: MES
Decision date: 2004-10-15
Classification: Gastroenterology, Urology
Generic name: STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
Approval order statement: APPROVAL FOR THE USE OF NUSIL MED 360 (1,000 CP) TO LUBRICATE THE DELIVERY TOOL AND TO CHANGE THE POSITIONING OF THE GRAPPLE PORTION OF THE DELIVERY TOOL.

Current openFDA PMA Record#

Device: UROLUME ENDOPROSTHESIS
Applicant: Boston Scientific Corp
PMA number: P920023
Supplement: S018
Product code: MES
Generic name: STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
Decision date: 2004-10-15
Decision code: APPR
Date received: 2004-09-30
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE USE OF NUSIL MED 360 (1,000 CP) TO LUBRICATE THE DELIVERY TOOL AND TO CHANGE THE POSITIONING OF THE GRAPPLE PORTION OF THE DELIVERY TOOL.