|
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 | S013 |
Date Received | 08/17/2016 |
Decision Date | 02/01/2017 |
Withdrawal Date
|
01/22/2020 |
Product Code |
NIO |
Advisory Committee |
Cardiovascular |
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 updated in-process sampling requirements and to remove redundant inspections. |