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.
| Device ID | K172145 |
| 510k Number | K172145 |
| 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 |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Medela AG Lattichstrasse 4b Baar, CH 6341 |
| Contact | Georges Hakim |
| Correspondent | Adrienne Lenz Hyman, Phelps, & McNamara, P.C. 700 Thirteenth Street NW Suite 1200 Washington, DC 20005 -5929 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-17 |
| Decision Date | 2018-05-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30020451458930 | K172145 | 000 |
| 30020451458923 | K172145 | 000 |
| 30020451458916 | K172145 | 000 |