Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICES
• Generic Name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
• Applicant: MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT; 8200 CORAL SEA STREET N.E.; MOUNDS VIEW, MN 55112
• PMA Number: P010031
• Supplement Number: S381
• Date Received: 05/29/2013
• Decision Date: 04/10/2014
• Product Code: NIK
• Docket Number: 14M-0553
• Notice Date: 05/08/2014
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT00267098
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: Yes
• Combination Product: No

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.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2