5086 MRI CAPSUREFIX MRI SURESCAN LEADS

FDA premarket approval P090013/S200 · decided 2015-09-11

Approval details

PMA number

P090013

Supplement

S200

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

5086 MRI CAPSUREFIX MRI SURESCAN LEADS

Generic name

Implantable pulse generator, pacemaker (non-CRT)

Applicant

Medtronic, Inc.

Date received

2015-03-16

Decision date

2015-09-11

Days to decision

179 days

Decision code

APPR

Product code

LWP

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

510(k) clearances by this applicant