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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 FAMILY OF LEADS
Generic NamePermanent defibrillator electrodes
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP950022
Supplement NumberS070
Date Received04/30/2010
Decision Date06/22/2010
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 A LABELING CHANGE FROM SJ-4 TO DF-4 FOR ST. JUDE MEDICAL HIGH VOLTAGE LEAD, IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PRODUCTS.
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