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Device | Evera MRIS XT DR/XT VR/S DR/S VR SureScan, Visia AF MRI XT and S VR SureScan, Primo MRI SureScan and Mirro MRI SureScan |
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 | S668 |
Date Received | 04/13/2018 |
Decision Date | 06/28/2018 |
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 | Yes |
Approval Order Statement Approval for an update to the indications for use to include pacing at the bundle of His. The device, as modified, will be marketed under the trade name SelectSecure MRI SureScan Lead Model 3830 and is indicated for: The Model 3830 lead is intended for pacing and sensing in the atrium or right ventricle. It is also intended for pacing and sensing at the bundle of His as an alternative to right ventricular pacing in a single or dual chamber pacing system. |