PMA P020036S034

Device
CORDIS SMART AND SMART CONTROL NITINOL STENT SYSTEMS VARIOUS
Applicant
Cordis US Corporation
PMA number
P020036
Supplement
S034
Product code
NIO
Decision date
2015-05-28
Classification
Stent, Iliac
Generic name
STENT, ILIAC
Approval order statement
USE AN ALTERNATE STABILIZING ADDITIVE IN PLASTIC COMPOUNDING PROCESSES.

Current openFDA PMA Record#

Device
CORDIS SMART AND SMART CONTROL NITINOL STENT SYSTEMS VARIOUS
Applicant
Cordis US Corporation
PMA number
P020036
Supplement
S034
Product code
NIO
Generic name
STENT, ILIAC
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.