PMA P160024S002

Device
LifeStream Balloon Expandable Vascular Covered Stent
Applicant
Bard Peripheral Vascular, Inc.
PMA number
P160024
Supplement
S002
Product code
PRL
Decision date
2017-10-13
Classification
Iliac Covered Stent, Arterial
Generic name
Iliac covered stent, arterial
Approval order statement
Approval for a minor change to the design of the stent guard component.

Current openFDA PMA Record#

Device
LifeStream Balloon Expandable Vascular Covered Stent
Applicant
Bard Peripheral Vascular, Inc.
PMA number
P160024
Supplement
S002
Product code
PRL
Generic name
Iliac covered stent, arterial
Decision date
2017-10-13
Decision code
APPR
Date received
2017-09-27
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a minor change to the design of the stent guard component.