|
Device | DRIVER & MICRO-DRIVER CORONARY STENT SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P030009 |
Supplement Number | S026 |
Date Received | 07/16/2008 |
Decision Date | 09/11/2008 |
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 THE INTRODUCTION OF ADDITIONAL AUTOMATION TO THE BALLOON SUB-ASSEMBLY MANUFACTURING PROCESS FOR THE DEVICE. |