CARELINK MONITOR,CARDIOSIGHT READER,CARELINK EXPRESS,DEVICE DATA MANAGEMENT APPLICATION(DDMA)

FDA premarket approval P890003/S309 · decided 2014-07-03

Approval details

PMA number

P890003

Supplement

S309

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

CARELINK MONITOR,CARDIOSIGHT READER,CARELINK EXPRESS,DEVICE DATA MANAGEMENT APPLICATION(DDMA)

Generic name

Pulse generator, permanent, implantable

Applicant

Medtronic, Inc.

Date received

2014-04-11

Decision date

2014-07-03

Days to decision

83 days

Decision code

APPR

Product code

NVZ

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR THE VIVA/BRAVA QUADRIPOLAR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICES AND IS INDICATED FOR PATIENTS WHO REQUIRE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE- THREATENING VENTRICULAR ARRHYTHMIAS, FOR USE IN PATIENTS WITH ATRIAL TACHYARRHYTHMIAS, OR THOSE PATIENTS WHO ARE AT SIGNIFICANT RISK FOR DEVELOPING ATRIAL TACHYARRHYTHMIAS AND FOR PROVIDING CARDIAC RESYNCHRONIZATION THERAPY IN HEART FAILURE PATIENTS ON ST

510(k) clearances by this applicant