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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 S PERMANENT PACING LEAD MODELS
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP960030
Supplement NumberS010
Date Received02/11/2003
Decision Date04/10/2003
Product Code DTB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR REDUCED LEAD BODY SIZE FOR THE PASSIVE PLUS DX LEAD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ISOFLEX S AND IS INDICATED FOR USE IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR TO PROVIDE PERMANENT PACING AND SENSING IN EITHER THE ATRIUM (MODELS 1643K AND 1642T) OR VENTRICLE (MODELS 1645K AND 1646T).
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