The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Ps Medical Neurosurgical Implants.
| Device ID | K042198 |
| 510k Number | K042198 |
| Device Name: | PS MEDICAL NEUROSURGICAL IMPLANTS |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117 |
| Contact | Jeffrey Henderson |
| Correspondent | Jeffrey Henderson MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-13 |
| Decision Date | 2004-09-24 |
| Summary: | summary |