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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDURATA LEAD MODELS
Generic NamePermanent defibrillator electrodes
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP950022
Supplement NumberS060
Date Received05/14/2009
Decision Date07/10/2009
Product Code NVY 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR PASSIVE FIXATION DURATA LEADS WITH SJ4 FOUR-POLE PROXIMAL CONNECTORS; MODEL NUMBERS 7170Q AND 7171Q.
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