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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 STS LEAD MODEL 2088TC
Generic NameDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP960013
Supplement NumberS046
Date Received03/31/2009
Decision Date05/26/2009
Product Code NVN 
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 DISTAL TIP CHANGES TO THE TENDRIL ST MODEL 1888 LEAD FAMILY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TENDRIL STS MODEL 2088TC, AND ARE TRANSVENOUS STEROID ELUTING LEADS INDICATED FOR USE IN THE RIGHT ATRIUM OR RIGHT VENTRICLE, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR.
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