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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(R) TRANSVENE LEAD SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namepacer cardioverter defibrillator
Applicant MEDTRONIC INC.
PMA NumberP920015
Supplement NumberS004
Date Received01/20/1995
Decision Date08/14/1995
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the transvene lead technical manuals.
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