PMA P120002S010

Device
CORDIS SMART AND SMART CONTROL VASCULAR STENT SYSTEMS
Applicant
Cordis US Corporation
PMA number
P120002
Supplement
S010
Product code
NIP
Decision date
2015-05-28
Classification
Stent, Superficial Femoral Artery
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement
USE AN ALTERNATE STABILIZING ADDITIVE IN PLASTIC COMPOUNDING PROCESSES.

Current openFDA PMA Record#

Device
CORDIS SMART AND SMART CONTROL VASCULAR STENT SYSTEMS
Applicant
Cordis US Corporation
PMA number
P120002
Supplement
S010
Product code
NIP
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Decision date
2015-05-28
Decision code
OK30
Date received
2015-05-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
USE AN ALTERNATE STABILIZING ADDITIVE IN PLASTIC COMPOUNDING PROCESSES.