|
Device | INTEGRITY CORONARY STENT STYSTEMS |
Generic Name | STENT, CORONARY |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P030009 |
Supplement Number | S074 |
Date Received | 02/03/2014 |
Decision Date | 03/04/2014 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A RECONCILIATION PROCESS FOR COMPLIANCE CHART LABELS. |