The following data is part of a De Novo classification by Kci Usa, Inc. with the FDA for Prevena 125 And Prevena Plus 125 Therapy Units.
| DeNovo ID | DEN180013 |
| Device Name: | PREVENA 125 And PREVENA PLUS 125 Therapy Units |
| Applicant | KCI USA, Inc. 6203 Farinon Drive San Antonio, TX 78249 |
| Contact | Kimberly Mccoy |
| Product Code | QFC |
| Decision | Granted (DENG) |
| Review Advisory Board | General & Plastic Surgery |
| Type | Direct |
| Date Received | 2018-03-15 |
| Decision Date | 2019-04-19 |