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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.
 
DeviceMEDTRONIC JEWEL CARDIOVERTER DEFIBRILLATOR
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator (non-crt)
Applicant
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP900061
Supplement NumberS023
Date Received04/03/1996
Decision Date09/25/1996
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR MODEL 9895E APPLICATION SOFTWARE, VERSION T6E6V3, FOR MODEL 9790 AND 9790C PROGRAMMERS WHICH PROGRAM THE MODELS 7616/7217, 7201, 7219/02 AND 7220 IMPLANTABLE ARRHYTHMIA MANAGEMENT DEVICES
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