The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Codman Certas Plus Programmable Valve.
| Device ID | K152152 |
| 510k Number | K152152 |
| Device Name: | Codman Certas Plus Programmable Valve |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | Medos International Sarl Chemin-Blanc 38 Le Locle, CH Ch-2400 |
| Contact | Jocelyn Raposo |
| Correspondent | Jocelyn Raposo Medos International Sarl Chemin-Blanc 38 Le Locle, CH Ch-2400 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-03 |
| Decision Date | 2015-10-27 |
| Summary: | summary |