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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endovascular suturing system
Regulation Description Endovascular Suturing System.
Definition Provides fixation and sealing between and endovascular graft and the native artery.
Product CodeOTD
Regulation Number 870.3460
Device Class 2


Premarket Reviews
ManufacturerDecision
APTUS ENDOSYSTEMS, INC.
  CLEARED FOR MARKETING AUTOMATIC CLASS III DESIGNAT 1
  SUBSTANTIALLY EQUIVALENT 2

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