EVERA MRI XT DR, XT VR, S DR, S VR SURESCAN ICD'S

FDA premarket approval P980016/S536 · decided 2015-09-11

Approval details

PMA number

P980016

Supplement

S536

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

EVERA MRI XT DR, XT VR, S DR, S VR SURESCAN ICD'S

Generic name

Implantable cardioverter defibrillator (non-CRT)

Applicant

Medtronic Cardiac Rhythm Disease Management

Date received

2015-03-16

Decision date

2015-09-11

Days to decision

179 days

Decision code

APPR

Product code

LWS

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL OF THE EVERA MRI XT/S DR AND VR IMPLANTABLE CARDIOVERTERDEFIBRILLATOR DEVICES AND PROGRAMMER APPLICATION SOFTWARE MODEL SW033 AS WELL AS EXTENSION OF MR CONDITIONAL LABELING AND USE FOR SPRINT QUATTRO SECURE LEAD MODELS 6935M AND 6947M AS MRI SURESCAN LABELED 55 AND 62CM LEADS. IN ADDITION TO THE SYSTEM COMPONENTS LISTED, THE USE OF THE CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI AND CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076 WITH THE EVERA MRI DR (DUAL CHAMBER)SYSTEM WHEN AN ATRIAL P