PMA P070014S067

Device
LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM
Applicant
Bard Peripheral Vascular, Inc.
PMA number
P070014
Supplement
S067
Product code
NIP
Decision date
2026-03-10
Classification
Cardiovascular
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement
approval for modifications to the packaging of the LifeStent and LifeStent XL Vascular Stent System.

Current openFDA PMA Record#

Device
LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM
Applicant
Bard Peripheral Vascular, Inc.
PMA number
P070014
Supplement
S067
Product code
NIP
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Decision date
2026-03-10
Decision code
APPR
Date received
2025-12-10
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
approval for modifications to the packaging of the LifeStent and LifeStent XL Vascular Stent System.