CapSureFix Novus MRi SureScan Lead and CapSureFix Novus MRI SureScan Lead

FDA premarket approval P930039/S186 · decided 2018-06-28

Approval details

PMA number

P930039

Supplement

S186

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

CapSureFix Novus MRi SureScan Lead and CapSureFix Novus MRI SureScan Lead

Generic name

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

Applicant

Medtronic, Inc.

Date received

2018-04-13

Decision date

2018-06-28

Days to decision

76 days

Decision code

APPR

Product code

NVN

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

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.

510(k) clearances by this applicant