K964172 is an FDA 510(k) clearance for the MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS OR TTL. 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 July 3, 1997, 258 days after receiving the submission on October 18, 1996.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5880.
| 510(k) Number | K964172 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 1996 |
| Decision Date | July 03, 1997 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZB — Stimulator, Spinal-cord, Implanted (pain Relief) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5880 |