The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Polyether Urethane Material Change In Neurostimulation Leads.
| Device ID | K040568 |
| 510k Number | K040568 |
| Device Name: | POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | MEDTRONIC VASCULAR 710 MEDTRONIC PARKWAY NE Minneapolis, MN 55432 -5604 |
| Contact | Doug Atkins |
| Correspondent | Doug Atkins MEDTRONIC VASCULAR 710 MEDTRONIC PARKWAY NE Minneapolis, MN 55432 -5604 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-04 |
| Decision Date | 2004-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978926452 | K040568 | 000 |
| 00885074473703 | K040568 | 000 |