The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Resume Ii Lead Kit For Spinal Cord Stimulation (scs) And Peripheral Nerve Stimulation (pns), Resume Tl Lead Kit For.
| Device ID | K032561 |
| 510k Number | K032561 |
| Device Name: | RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | MEDTRONIC VASCULAR 710 MEDTRONIC PARKWAY Minneapolis, MN 55432 |
| Contact | Lucy Tan |
| Correspondent | Lucy Tan MEDTRONIC VASCULAR 710 MEDTRONIC PARKWAY Minneapolis, MN 55432 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-20 |
| Decision Date | 2003-09-11 |
| Summary: | summary |