|
Device | EVERA MRI XT DR/VR SURESCAN,EVERA MRI S DR/VR SURESCAN ICDS AND PROGRAMMER SOFTWARE |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MS MVS11 MOUNDS VIEW, MN 55112 |
PMA Number | P980016 |
Supplement Number | S555 |
Date Received | 10/13/2015 |
Decision Date | 04/28/2016 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the expansion of MRI conditional labeling for the Advisa and Evera SureScan Systems to 3T MRI. |
Post-Approval Study | Show Report Schedule and Study Progress |