The following data is part of a De Novo classification by Medtronic Neurosurgery with the FDA for Medtronic Duet External Drainage And Monitoring System.
| DeNovo ID | DEN120017 |
| Device Name: | Medtronic DUET External Drainage And Monitoring System |
| Classification | External Cerebrospinal Fluid (csf) Diversion |
| Applicant | MEDTRONIC NEUROSURGERY 125 Cremona Dr. Goleta, CA 93117 |
| Contact | Donovan May |
| Product Code | PCB |
| CFR Regulation Number | 882.5560 [🔎] |
| 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 | Neurology |
| Classification Advisory | Neurology |
| Type | Post-NSE |
| Date Received | 2012-12-21 |
| Decision Date | 2014-08-22 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000396008 | DEN120017 | 000 |
| 00763000428723 | DEN120017 | 000 |
| 00763000624804 | DEN120017 | 000 |
| 00763000624798 | DEN120017 | 000 |
| 00763000624781 | DEN120017 | 000 |
| 00763000624774 | DEN120017 | 000 |
| 00763000624767 | DEN120017 | 000 |
| 00763000624750 | DEN120017 | 000 |
| 00763000624743 | DEN120017 | 000 |
| 00763000428730 | DEN120017 | 000 |
| 00763000428747 | DEN120017 | 000 |
| 00763000428754 | DEN120017 | 000 |
| 00763000406028 | DEN120017 | 000 |
| 00763000406011 | DEN120017 | 000 |
| 00763000406004 | DEN120017 | 000 |
| 00763000395971 | DEN120017 | 000 |
| 20763000431277 | DEN120017 | 000 |
| 00763000428785 | DEN120017 | 000 |
| 00763000428778 | DEN120017 | 000 |
| 00763000428761 | DEN120017 | 000 |
| 00763000281267 | DEN120017 | 000 |