PMA P070014S066

Device
LifeStent® Vascular Stent Systems
Applicant
Bard Peripheral Vascular, Inc.
PMA number
P070014
Supplement
S066
Product code
NIP
Decision date
2025-12-16
Classification
Cardiovascular
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement
changes to the stent electropolishing and final stent cleaning processes

Current openFDA PMA Record#

Device
LifeStent® Vascular Stent Systems
Applicant
Bard Peripheral Vascular, Inc.
PMA number
P070014
Supplement
S066
Product code
NIP
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Decision date
2025-12-16
Decision code
OK30
Date received
2025-12-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
changes to the stent electropolishing and final stent cleaning processes