|
Device | ADVISA MRI DR/SR SURESCAN IPGS AND PROGRAMMER SOFTWARE |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P980035 |
Supplement Number | S442 |
Date Received | 10/13/2015 |
Decision Date | 04/28/2016 |
Product Code |
NVZ |
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 expansion of MRI conditional labeling for the Advisa and Evera SureScan systems to 3T MRI. |
Post-Approval Study | Show Report Schedule and Study Progress |