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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
TEPHA, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 8 8
2021 1 1
2022 7 7
2023 4 4
2024 1 1
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 12 12
Difficult to Open or Remove Packaging Material 4 4
Detachment of Device or Device Component 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Packaging Problem 2 2
Fracture 2 2
Melted 2 2
Break 1 1
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
Wound Dehiscence 3 3
No Consequences Or Impact To Patient 3 3
No Known Impact Or Consequence To Patient 1 1
No Patient Involvement 1 1

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