FDA Inspection
Medtronic NeuromodulationMedtronic Neuromodulation – FDA Inspection, Apr 3, 2013
Record Details
This FDA Inspection record concerns Medtronic Neuromodulation, with an inspection on April 3, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medtronic Neuromodulation
- Inspection Date
- April 3, 2013
- Product Type
- Devices
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ID · 6605c1c0-dfb7-4236-849b-c94e49a5fc6f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 823910
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - 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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