PMA P020036S025

Device
SMART NITINOL STENT SYSTEM AND SMART CONTROL NITINOL STENT SYSTEM
Applicant
Cordis US Corporation
PMA number
P020036
Supplement
S025
Product code
NIO
Decision date
2012-05-22
Classification
Stent, Iliac
Generic name
STENT, ILIAC
Approval order statement
IMPLEMENTATION OF A VISION SYSTEM FOR THE INSPECTION OF POUCH SEALS.

Current openFDA PMA Record#

Device
SMART NITINOL STENT SYSTEM AND SMART CONTROL NITINOL STENT SYSTEM
Applicant
Cordis US Corporation
PMA number
P020036
Supplement
S025
Product code
NIO
Generic name
STENT, ILIAC
Decision date
2012-05-22
Decision code
OK30
Date received
2012-04-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
IMPLEMENTATION OF A VISION SYSTEM FOR THE INSPECTION OF POUCH SEALS.