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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 2088TC, OptiSense Low Voltage Pacing Leads
Generic NameDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP960013
Supplement NumberS122
Date Received09/30/2022
Decision Date05/11/2023
Product Code NVN 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for the UltiPace Model LPA1231 pacing lead, which incorporates several design and manufacturing modifications to the existing Tendril STS 2088TC lead on the proximal end of the lead.
Post-Approval StudyShow Report Schedule and Study Progress
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