|
Device | DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS |
Generic Name | STENT, CORONARY |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P030009 |
Supplement Number | S050 |
Date Received | 11/15/2010 |
Decision Date | 04/12/2011 |
Product Code |
MAF |
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 A CHANGE TO ALLOW THE REMOVAL OF THE IN-PROCESS FUNCTIONAL TESTING COMPLETED ON THE STENTS OF DRIVER AND MICRO-DRIVER CORONARY STENT SYSTEMS AND ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS. |