Company
Medtronic Inc, Neurological & Spinal Division
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 25, 2006 | Medtronic Inc, Neurological & Spinal Division Medtronic Model 37711 Restore Neurostimulator. The Restore Neurostimulator is an implanted, rechargeable neurostimulator which provides pain management therapy. Terminated |
GZB | None listed |
| Jan 10, 2006 | Medtronic Inc, Neurological & Spinal Division Medtronic Activa Deep Brain Stimulation (DBS) system including the following system components: Model 7424 Itrel II Neurostimulator (DBS applications only); Model 7426 Soletra Neurostimulator; Model Terminated |
MHY | None listed |
| Jan 13, 2005 | Medtronic Inc, Neurological & Spinal Division Model 8561 Lioresal (Baclofen injection) Intrathecal Refill Kit is designed for refilling the Medtronic SynchroMed family of pumps. The 8561 kit contains a 1-20 ml ampule of 500 mcg/ml Baclofen injec Terminated |
LKK | None listed |
| Sep 23, 2004 | Medtronic Inc, Neurological & Spinal Division 8870 software application card versions AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N''Vision Clinician Programmer. Terminated |
LKK | None listed |
| Aug 24, 2004 | Medtronic Inc, Neurological & Spinal Division The Model 8540 Catheter Access Port Kit is intended for use in accessing the catheter via the catheter access port of Medtronic(R) implantable programmable infusion pumps (except Medtronic MiniMed pum Terminated |
LKK | None listed |
| Jul 20, 2004 | Medtronic Inc, Neurological & Spinal Division Synchromed II infusion pump Terminated |
FRN | None listed |