|
Device | ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM |
Generic Name | STENT, ILIAC |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P110011 |
Supplement Number | S002 |
Date Received | 03/22/2012 |
Decision Date | 08/16/2012 |
Withdrawal Date
|
01/22/2020 |
Product Code |
NIO |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00753337
|
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO AUTOMATE THE INFORMATION MANAGEMENT SYSTEM. |