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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

Parietene Flat Sheet Mesh

Manufacturer

Medtronic - Sofradim Production

Date Cleared

2025-10-24

(29 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Reference & Predicate Devices

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Parietene™ flat Sheet Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving abdominal wall hernias repair.

Device Description

Parietene™ Flat Sheet Mesh is a Monofilament polypropylene mesh.

AI/ML Overview

N/A

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