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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in repair or replacement of chordae tendinae. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s).
Technical Method provides tension between the papilary muscles and valve leaflets to prevent valve leaflet prolapse by restoring natural function of the chordae tendinae.
Target Area Mitral and Tricuspid valve apparatus.
Regulation Medical Specialty General & Plastic Surgery
Review Panel Cardiovascular
Product CodePAW
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Vascular Surgery Devices Branch (VSDB)
Submission Type 510(k)
Regulation Number 878.5035
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible