Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

Basic Information

• Device Name: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
• Trade Name: BRAVA CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA ICD, INSYNC II PROTECT ICD ,III MARQUIS ICD, INSYNC MAXIMO ICD,
• PMA Number: P010031
• Supplement Number: S455
• Device Class: FDA Class 3
• Product Code: NIK
• Generic Name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
• Medical Specialty: Unknown
• Advisory Committee: Cardiovascular
• Decision: Approved
• Decision Code: APPR
• Decision Date: January 26, 2015
• Date Received: July 18, 2014
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review: N

Advisory Committee Statement

APPROVAL FOR THE MYCARELINK SMART MONITOR USED WITH THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYCARELINK SMART MONITOR ANDTHE MYCARELINK HEART APPLICATION AND IS INDICATED FOR:PATIENT READER INDICATIONS FOR USE:THE PATIENT READER IS A PORTABLE ELECTRONIC DEVICE THAT COMMUNICATES WITH YOUR MEDTRONICIMPLANTED HEART DEVICE. THE APPLICATION ON SMART PHONE OR TABLET TRANSMITS IMPLANTED HEARTDEVICE DATA TO THE MEDTRONIC CARELINK NETWORK. MOBILE APPLICATION INDICATIONS FOR USE:THE MEDTRONIC MYCARELINK HEART APPLICATION TRANSMITS IMPLANTED HEART DEVICE DATA TO THE CARELINK NETWORK VIA A MOBILE DEVICE.

Classifications

This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

Product Code	Device Name	Device Class	Medical Specialty
NIK	Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	FDA class 3	Unknown

Applicant

• Name: MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
• Address: 8200 CORAL SEA STREET N.E., MOUNDS VIEW, MN, 55112