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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.
 
Trade NameMEDTRONIC PACING LEADS
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator
Regulation Number870.3610
ApplicantMEDTRONIC VASCULAR
PMA NumberP890003
Supplement NumberS068
Date Received10/15/2001
Decision Date03/01/2002
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for medtronic model 72 dr dual chamber implantable cardioverter defibrillator system with m dr) application software, model 9990 desktop software, model 9322 patient magnet, and model 9767/9767l telemetry programming head (telemetry b). The device, as modified, will be marketed under the trade name medtronic m dr dual chamber implantable cardioverter defibrillator system and is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
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