PMA P010031S381

Device

CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICES

Applicant

Medtronic Cardiac Rhythm Disease Management

PMA number

P010031

Supplement

S381

Product code

NIK

Decision date

2014-04-10

Classification

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)

Generic name

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Approval order statement

APPROVAL FOR THE EXPANSION OF THE INDICATIONS FOR USE OF THE CRT-P AND CRT-D DEVICES TO INCLUDE NYHA FUNCTIONAL CLASS I, II, OR III PATIENTS WHO HAVE A LEFT VENTRICULAR EJECTION FRACTION (LVEF) =< 50% ARE ON STABLE, OPTIMAL HEART FAILURE MEDICAL THERAPY IF INDICATED, AND HAVE ATRIOVENTRICULAR BLOCK (AV BLOCK) THAT IS EXPECTED TO REQUIRE A HIGH PERCENTAGE OF VENTRICULAR PACING THAT CANNOT BE MANAGED WITH ALGORITHMS TO MINIMIZE RIGHT VENTRICULAR PACING. THESE DEVICES ARE INDICATED FOR THE CONSULTA CRT-D MODEL D224TRK, CONCERTO II CRT-D MODEL D274TRK, CONSULTA CRT-D MODEL D204TRM, PROTECTA XT CRT-D MODEL D314TRM, PROTECTA CRT-D MODEL D334TRM, PROTECTA XT CRT-D MODEL D314TRG, PROTECTA CRT-D MODEL D334TRG, VIVA XT CRT-D MODEL DTBA1D4, VIVA XT CRT-D MODEL DTBA1D1, VIVA S CRT-D MODEL DTBB1D4, AND VIVA S CRT-D MODEL DTBB1D1: FOR ADDITIONAL INFORMATION PLEASE REFER TO THE APPROVAL ORDER.

Summary

<a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P010031S381B.pdf" target="_new">Summary of Safety and Effectiveness</a>