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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 7221 B/C/CX/D/E MICRO JEWEL W/MODEL 5434 ACTIVE CAN EMULATOR AND MODEL 9894
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namearrhythmia management devices
ApplicantMEDTRONIC VASCULAR
PMA NumberP900061
Supplement NumberS022
Date Received02/15/1996
Decision Date07/01/1996
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for medtronic model 7221 b/c/cx/d/e micro jewel with the model 5434 active can emulator and model 9894 software.
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