FDA Inspection
Medtronic NeuromodulationMedtronic Neuromodulation – FDA Inspection, Oct 26, 2015
Record Details
This FDA Inspection record concerns Medtronic Neuromodulation, with an inspection on October 26, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medtronic Neuromodulation
- Inspection Date
- October 26, 2015
- Product Type
- Devices
View Company Profile
ID · 6a65256d-6207-4fc7-bb63-7c32e5fa8b70
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 966611
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
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Other FDA inspections of Medtronic Neuromodulation
15| Date | Classification | Office | Project area |
|---|---|---|---|
| May 5, 2023 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 3, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 9, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 17, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 6, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medtronic Neuromodulation
- FDA Inspection 1206222 - 2023-05-05
- FDA Inspection 1187313 - 2022-11-03
- FDA Inspection 1153966 - 2021-09-09
- FDA Inspection 1108789 - 2019-10-17
- FDA Inspection 1102180 - 2019-08-06
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