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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mesh, surgical, absorbable, plastic and reconstructive surgery
Regulation Description Surgical mesh.
Definition For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.
Product CodeOXF
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLERGAN, INC.
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 176
No code available 105
Patient-device incompatibility 69
Material disintegration 15
No Information 3
Difficult to remove 2
Use of Device Issue 2
Buckled material 2
Not Applicable 1
Folded 1
Migration of device or device component 1
Total Device Problems 377

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