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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceTACHOS DR ATRIAL TX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ICD SYSTEM
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP000009
Supplement NumberS004
Date Received03/22/2002
Decision Date09/09/2002
Product Code MRM 
Docket Number 07M-0408
Notice Date 11/09/2007
Advisory Committee Cardiovascular
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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