PMA P070014S064

Device
LifeStent™ 5F Vascular Stent Systems
Applicant
Bard Peripheral Vascular, Inc.
PMA number
P070014
Supplement
S064
Product code
NIP
Decision date
2023-02-02
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement
New supplier for a delivery system wheel sub-assembly.

Current openFDA PMA Record#

Device
LifeStent™ 5F Vascular Stent Systems
Applicant
Bard Peripheral Vascular, Inc.
PMA number
P070014
Supplement
S064
Product code
NIP
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Decision date
2023-02-02
Decision code
OK30
Date received
2023-01-06
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New supplier for a delivery system wheel sub-assembly.