TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large)

Mesh, Surgical, Polymeric

Medtronic, Inc.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Tyrx Neuro Absorbable Antibacterial Envelope (medium), Tyrx Neuro Absorbable Antibacterial Envelope (large).

Pre-market Notification Details

Device IDK192636
510k NumberK192636
Device Name:TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large)
ClassificationMesh, Surgical, Polymeric
Applicant Medtronic, Inc. 8200 Coral Sea St NE Mounds View,  MN  55112
ContactNancy Cameron
CorrespondentNancy Cameron
Medtronic, Inc. 8200 Coral Sea St NE Mounds View,  MN  55112
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-23
Decision Date2020-04-08

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