The following data is part of a De Novo classification by Micro Interventional Devices, Inc. with the FDA for Permaseal.
| DeNovo ID | DEN150029 |
| Device Name: | Permaseal |
| Classification | Apical Closure Device |
| Applicant | MICRO INTERVENTIONAL DEVICES, INC. 5 Caufield Pl. Suite 102 Newtown, PA 18940 |
| Contact | Linda Morgan |
| Product Code | PNQ |
| CFR Regulation Number | 870.4510 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Cardiovascular |
| Classification Advisory | Cardiovascular |
| Type | Direct |
| Date Received | 2015-06-22 |
| Decision Date | 2016-07-27 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |