PMA P070014S054

Device
BARD LIFESTENT and LifeStent CLVascular Stent System
Applicant
Bard Peripheral Vascular, Inc.
PMA number
P070014
Supplement
S054
Product code
NIP
Decision date
2017-10-23
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement
Modifications to the frequency of in-process packaging and stent delivery system testing.

Current openFDA PMA Record#

Device
BARD LIFESTENT and LifeStent CLVascular Stent System
Applicant
Bard Peripheral Vascular, Inc.
PMA number
P070014
Supplement
S054
Product code
NIP
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Decision date
2017-10-23
Decision code
OK30
Date received
2017-09-21
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modifications to the frequency of in-process packaging and stent delivery system testing.