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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 SPRINT FAMILY OF TRANSVENOUS DEFIBRILLATION LEADS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namepacer cardioverter defibrillator
Applicant MEDTRONIC INC.
PMA NumberP920015
Supplement NumberS016
Date Received08/12/1999
Decision Date09/24/1999
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding a caution label to the medtronic(r) sprint(tm) lead models 6932, 6937, 6942, 6943 and 6945.
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