The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Model 5328 Program-stimulator.
| Device ID | K851091 |
| 510k Number | K851091 |
| Device Name: | MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR |
| Classification | Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) |
| Applicant | MEDTRONIC VASCULAR 800 53RD AVENUE, NE P.O. BOX 1250 Minneapolis, MN 55440 -9087 |
| Contact | Johnson |
| Correspondent | Johnson MEDTRONIC VASCULAR 800 53RD AVENUE, NE P.O. BOX 1250 Minneapolis, MN 55440 -9087 |
| Product Code | JOQ |
| CFR Regulation Number | 870.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-18 |
| Decision Date | 1985-04-16 |