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

Basic Information

• Device Name: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
• Trade Name: AMPLIA MRI CRT-D & QUAD CRT-D; BRAVA CRT-D & QUAD CRT-D; CLARIA MRI CRT-D & QUAD CRT-D; COMPIA MRI CRT-D & QUAD CRT-D
• PMA Number: P010031
• Supplement Number: S574
• 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: 30-Day Notice Accepted
• Decision Code: OK30
• Decision Date: December 19, 2016
• Date Received: November 28, 2016
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review: N

Advisory Committee Statement

Updates to the inspection procedure for Titanium Dioxide containing pigment paste to allow usage of a new test method.

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