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. |
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Device | TACHOS DR IMPLANTALBLE 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 | S002 |
Date Received | 08/10/2001 |
Decision Date | 09/04/2001 |
Product Code |
MRM |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE EMBEDDED AND PROGRAMMER SOFTWARE FOR THE TACHOS DR. THE NEW VERSION NUMBER FOR THE SOFTWARE CARTRIDGE FOR TACHOS DR/PHYLAX AV/TMS 1000 APPLICATIONS IS I-HDR.0.U/4 (MODEL 338 373). THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME TACHOS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM AND IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS. |
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