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[DOI] [PubMed] [Google Scholar] 170.Tlak Gajger I., Smodis Skerl M.I., Sostaric P., Suran J., Sikiric P., Vlainic J

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The applicant stated that it is seeking FDA approval for the Aveir TM Dual-Chamber Leadless Pacemaker for the same indications listed on the Breakthrough Device designation