The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Model 3586 Resume Lead.
| Device ID | K913934 |
| 510k Number | K913934 |
| Device Name: | MEDTRONIC MODEL 3586 RESUME LEAD |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Contact | Daryle Peterson |
| Correspondent | Daryle Peterson MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-03 |
| Decision Date | 1992-01-22 |