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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device nonabsorbable expanded polytetrafluoroethylene surgical suture for chordae tendinae repair or replacement
Regulation Description Nonabsorbable expanded polytetrafluoroethylene surgical suture.
Definition To repair or replace chordae tendinae.
Product CodePAW
Regulation Number 878.5035
Device Class 2


Premarket Reviews
ManufacturerDecision
ON-X LIFE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

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