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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namedefibrillator, implantable, dual-chamber
Generic Namedefibrillator, implantable, dual-chamber
6024 jean road
lake oswego, OR 97035
PMA NumberP000009
Supplement NumberS001
Date Received12/13/2000
Decision Date03/05/2001
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for a new icd system which includes the following: tachos dr icd (model 335572), tachos dr test housing (model 122068), and tachos dr and tms 1000 application software i-hdr. 0. U (model 334802). The device, as modified, will be marketed under the trade name tachos dr implantable cardioverter defibrillator system and is indicated for ventricular antitachycardia pacing and ventricular defibrillation, for automated treatment of life-threatening venticular arrhythmias.