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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.
 
DeviceISOFLEX OPTIM LEADS
Generic NamePermanent defibrillator electrodes
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP960030
Supplement NumberS020
Date Received01/17/2008
Decision Date03/18/2008
Product Code NVY 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR DEVICE MODIFICATIONS TO THE ISOFLEX OPTIM FAMILY OF LEADS. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ISOFLEX OPTIM MODEL 1944T AND ISOFLEX OPTIM 1948T.
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