|
Device | Capsure Sense MRI SureScan Lead Model 4074, Capsure Sense MRI SureScan Lead Model 4574 |
Generic Name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P830061 |
Supplement Number | S127 |
Date Received | 03/11/2016 |
Decision Date | 09/07/2016 |
Product Code |
NVN |
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 1.5 and 3T MR-conditional labeling for MRI SureScan lead Models 4074, 4574, and 4076 when used with currently approved SureScan MR-conditional devices. |