PMA P020036S023

Device
NITINOL STENT SYSTEM AND SMART CONTROL NITINOL STENT SYSTEM
Applicant
Cordis US Corporation
PMA number
P020036
Supplement
S023
Product code
NIO
Decision date
2012-03-22
Classification
Stent, Iliac
Generic name
STENT, ILIAC
Approval order statement
PACKAGE HANDLING CHANGE TO THE HEAT SEALING PROCESS.

Current openFDA PMA Record#

Device
NITINOL STENT SYSTEM AND SMART CONTROL NITINOL STENT SYSTEM
Applicant
Cordis US Corporation
PMA number
P020036
Supplement
S023
Product code
NIO
Generic name
STENT, ILIAC
Decision date
2012-03-22
Decision code
OK30
Date received
2012-02-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
PACKAGE HANDLING CHANGE TO THE HEAT SEALING PROCESS.