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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tracheal prosthesis with cover material derived from human sources
Definition The tracheal prosthesis with cover material derived from human sources is an expandable tubular device made of a metal material covered with a human-sourced decellularized material. It is intended to be implanted to restore the structure and/or function of the trachea or tracheobronchial tree. This device may also include a device delivery system. This device type does not include products that are intended to promote regeneration, impede inflammatory cascades, and release growth factors.
Product CodeSDB
Regulation Number 868.3721
Device Class 2


Premarket Reviews
ManufacturerDecision
PEYTANT SOLUTIONS, INC.
  GRANTED 1

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