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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 MODELS 7230CX, 7230B, AND 7230E MARQUIS VR SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS WITH
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber icds
ApplicantMEDTRONIC VASCULAR
PMA NumberP980016
Supplement NumberS029
Date Received06/28/2002
Decision Date12/17/2002
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for medtronic models 7230cx, 7230b, and 7230e marquis vr single chamber implantable cardioverter defibrillator (icd) systems with model 9967 (marquis vr) application software for use with the commercially available model 9322 patient magnet, the model 9790c programming system [9790c programmer, model 9990 desktop software and model 9767/9767l telemetry programming head (telemetry b)] and with the model 2090 programming system [2090 programmer, model 9986 desktop software and model 2067/2067l telemetry programming head (telemetry programming head (telemetry b)]. The device, as modified, will be marketed under the trade name medtronic marquis vr single 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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