K914433 is an FDA 510(k) clearance for the MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS. This device is classified as a Stimulator, Spinal-cord, Implanted (pain Relief) (Class II - Special Controls, product code GZB).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on December 23, 1991, 80 days after receiving the submission on October 4, 1991.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5880.
| 510(k) Number | K914433 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 1991 |
| Decision Date | December 23, 1991 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | GZB — Stimulator, Spinal-cord, Implanted (pain Relief) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5880 |