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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device suture, recombinant technology
Regulation Description Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
Definition Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation.
Product CodeNWJ
Regulation Number 878.4494
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
ENTRIGUE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TEPHA, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 3
TORNIER
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Packaging issue 10
Break 5
Difficult to open or remove packaging material 3
Failure to unwrap 2
Battery charger, defective 2
No code available 2
Device operates differently than expected 2
Failure to Adhere or Bond 1
No Known Device Problem 1
Detachment of device component 1
Material frayed 1
Device damaged prior to use 1
Detachment of device or device component 1
Total Device Problems 32

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