MEDTRONIC CAPSUREFIX NOVUS MRI SURESCAN MODEL 5076 LEAD

FDA premarket approval P930039/S107 · decided 2014-10-13

Approval details

PMA number

P930039

Supplement

S107

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

MEDTRONIC CAPSUREFIX NOVUS MRI SURESCAN MODEL 5076 LEAD

Generic name

Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Applicant

Medtronic, Inc.

Date received

2014-04-17

Decision date

2014-10-13

Days to decision

179 days

Decision code

APPR

Product code

NVN

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR ADDING THE 5076 CAPSUREFIX NOVUS LEAD TO THE MR CONDITIONALPACING FAMILY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CAPSUREFIX NOVUS MRI SURESCAN MODEL 5076 AND IS INDICATED FOR USE AS A SYSTEM CONSISTING OF A MEDTRONIC MRI SURESCAN IPG IMPLANTED WITH SURESCAN LEADS. A COMPLETE SYSTEM IS REQUIRED FOR USE IN THEMRI ENVIRONMENT.

510(k) clearances by this applicant