The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Medtronic Ps Medical Strata Valve.
| Device ID | K040943 |
| 510k Number | K040943 |
| Device Name: | MEDTRONIC PS MEDICAL STRATA VALVE |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | MEDTRONIC NEUROSURGERY 125 CREMONA DR., Goleta, CA 93117 |
| Contact | Jeff Henderson |
| Correspondent | Jeff Henderson MEDTRONIC NEUROSURGERY 125 CREMONA DR., Goleta, CA 93117 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-12 |
| Decision Date | 2004-06-15 |
| Summary: | summary |