The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Codman Certas Programmable Valve System, Codman Certas Therapy Management System.
| Device ID | K112156 |
| 510k Number | K112156 |
| Device Name: | CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | MEDOS INTERNATIONAL SARL 325 Paramount Drive Raynham, MA 02767 |
| Contact | Jocelyn Raposo |
| Correspondent | Jocelyn Raposo MEDOS INTERNATIONAL SARL 325 Paramount Drive Raynham, MA 02767 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-27 |
| Decision Date | 2011-10-17 |
| Summary: | summary |