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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

Device Problems
No Known Device Problem 171
No code available 91
Patient-device incompatibility 54
Material disintegration 15
No Information 3
Difficult to remove 2
Buckled material 2
Not Applicable 1
Use of Device Issue 1
Folded 1
Total Device Problems 341

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