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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 MODEL 7219C/7202C JEWEL ACTIVE CAN MANAGEMENT SYSTEMS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namepacing sys
ApplicantMEDTRONIC VASCULAR
PMA NumberP900061
Supplement NumberS014
Date Received07/03/1995
Decision Date12/06/1995
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the medtronic model 7219c/7202c jewel active can arrhythmia management systems. The model 7220c was withdrawn from the referenced application, and therefore approval is not granted for that model.
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