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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.
 
DeviceTENDRIL SDX PERMANENT PACEMAKER LEADS, MODELS 1688T/TC
Generic Namepermanent pacemaker Electrode
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP960013
Supplement NumberS013
Date Received04/23/2003
Decision Date06/13/2003
Product Codes DTB DXY 
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 ADDITION OF A FLUOROSCOPIC MARKER IN THE HELIX TIP, AND IS INDICATED FOR PERMANENT SENSING AND PACING IN EITHER THE ATRIUM OR THE VENTRICLE, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR.
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