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Device | TACHOS DR ATRIAL TX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ICD SYSTEM |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P000009 |
Supplement Number | S004 |
Date Received | 03/22/2002 |
Decision Date | 09/09/2002 |
Product Code |
MRM |
Docket Number | 07M-0408 |
Notice Date | 11/09/2007 |
Advisory Committee |
Cardiovascular |
Supplement Type | Panel Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE TACHOS DR ATRIAL TX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM, MODEL 122499 WITH SOFTWARE CARTRIDGE SWM / I-KDR.0.C, MODEL 339684. THE DEVICE IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS. THE DEVICE IS INDICATED FOR USE IN ICD PATIENTS WITH EITHER ATRIAL TACHYARRHYTHMIAS OR WHO ARE AT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |