Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 Days, Invia Motion – 60 Days, Invia Motion – 30 Days, Invia Motion – 15 Days, Invia Motion – 7 Days), Invia Liberty N

Negative Pressure Wound Therapy Powered Suction Pump

Medela AG

The following data is part of a premarket notification filed by Medela Ag with the FDA for Invia Foam Dressing Kits With Fitpad, Invia Motion Negative Pressure Wound Therapy System (invia Motion - Endure, Invia Motion – 120 Days, Invia Motion – 60 Days, Invia Motion – 30 Days, Invia Motion – 15 Days, Invia Motion – 7 Days), Invia Liberty N.

Pre-market Notification Details

Device IDK172145
510k NumberK172145
Device Name:Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 Days, Invia Motion – 60 Days, Invia Motion – 30 Days, Invia Motion – 15 Days, Invia Motion – 7 Days), Invia Liberty N
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant Medela AG Lattichstrasse 4b Baar,  CH 6341
ContactGeorges Hakim
CorrespondentAdrienne Lenz
Hyman, Phelps, & McNamara, P.C. 700 Thirteenth Street NW Suite 1200 Washington,  DC  20005 -5929
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-17
Decision Date2018-05-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30020451458930 K172145 000
30020451458923 K172145 000
30020451458916 K172145 000

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