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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device polymer, ear, nose and throat, synthetic, absorbable
Regulation Description Ear, nose, and throat synthetic polymer material.
Definition Ear, nose, and throat absorbable synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is shaped and formed by the surgeon to conform to the patient's needs. This generic type of device is made of absorbable synthetic polymer materials.
Product CodeNHB
Regulation Number 874.3620
Device Class 2


Premarket Reviews
ManufacturerDecision
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
MACROPORE BIOSURGERY
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
POLYGANICS BV
  SUBSTANTIALLY EQUIVALENT 1
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fracture 3
Other (for use when an appropriate device code cannot be identified) 3
No Known Device Problem 2
Total Device Problems 8

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