K032561 is an FDA 510(k) clearance for the RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR. This device is classified as a Stimulator, Spinal-cord, Implanted (pain Relief) (Class II - Special Controls, product code GZB).
Submitted by Medtronic Vascular (Miinneapolis, US). The FDA issued a Cleared decision on September 11, 2003, 22 days after receiving the submission on August 20, 2003.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5880.
| 510(k) Number | K032561 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 2003 |
| Decision Date | September 11, 2003 |
| Days to Decision | 22 days |
| Submission Type | Special |
| 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 |