The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Model 5328 Programmable Stimulator.
| Device ID | K861368 |
| 510k Number | K861368 |
| Device Name: | MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR |
| Classification | Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Contact | Timothy J Johnson |
| Correspondent | Timothy J Johnson MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Product Code | JOQ |
| CFR Regulation Number | 870.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-11 |
| Decision Date | 1986-08-04 |