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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 P LEAD FAMILY MODELS 1644T AND 1648T STEROID ELUTING, PASSIVE FIXATION ENDOCARDIAL PACING LEADS
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP960030
Supplement NumberS012
Date Received08/03/2004
Decision Date04/27/2005
Product Code DTB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A POLYURETHANE INSULATOR. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ISOFLEX P 1644T AND ISOFLEX P 1648T LEADS AND ARE INDICATED FOR USE IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR TO PROVIDE PERMANENT PACING AND SENSING IN EITHER THE ATRIUM (MODEL 1644T) OR VENTRICLE (MODEL 1648T).
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