FDA Inspection
Medtronic Vascular, Inc.Medtronic Vascular, Inc. – FDA Inspection, Nov 27, 2012
Record Details
This FDA Inspection record concerns Medtronic Vascular, Inc., with an inspection on November 27, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medtronic Vascular, Inc.
- Inspection Date
- November 27, 2012
- Product Type
- Devices
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ID · 30e861e1-9c77-464d-b586-896b6cfc99bc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 810454
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.43(c)No investigator agreement
- 21 CFR 812.140(b)(3)Sponsor records of investigator agreements inadequate
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Other FDA inspections of Medtronic Vascular, Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| July 11, 2019 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| August 31, 2017 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| November 7, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 14, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 22, 2013 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Medtronic Vascular, Inc.
- FDA Inspection 1096966 - 2019-07-11
- FDA Inspection 1030899 - 2017-08-31
- FDA Inspection 901694 - 2014-11-07
- FDA Inspection 855281 - 2013-11-14
- FDA Inspection 819376 - 2013-02-22
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