The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Spinal Cord Stimulation And Peripheral Nerve Stimulation Systems For Pain Relief.
| Device ID | K011584 |
| 510k Number | K011584 |
| Device Name: | MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | MEDTRONIC VASCULAR 800 53RD AVENUE, N.E. Minneapolis,, MN 55421 |
| Contact | David H Mueller |
| Correspondent | David H Mueller MEDTRONIC VASCULAR 800 53RD AVENUE, N.E. Minneapolis,, MN 55421 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-23 |
| Decision Date | 2001-06-22 |