PMA P920023S011

Device
UROLUME ENDOPROSTHESIS
Applicant
Boston Scientific Corp
PMA number
P920023
Supplement
S011
Product code
MES
Decision date
2000-02-09
Generic name
STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
Approval order statement
Modification to the delivery tool handle.

Current openFDA PMA Record#

Device
UROLUME ENDOPROSTHESIS
Applicant
Boston Scientific Corp
PMA number
P920023
Supplement
S011
Product code
MES
Generic name
STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
Decision date
2000-02-09
Decision code
APPR
Date received
2000-02-04
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Modification to the delivery tool handle.