FDA Inspection
AtriCure, Inc.AtriCure, Inc. – FDA Inspection, Mar 9, 2018
Record Details
This FDA Inspection record concerns AtriCure, Inc., with an inspection on March 9, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 08d8ec69-c96f-4675-a3d4-8e9b7fd70ccc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1055553
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
Other FDA inspections of AtriCure, Inc.
11| Date | Classification | Office | Project area |
|---|---|---|---|
| December 13, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| March 9, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 5, 2017 | Not classified | Cincinnati District Office | |
| August 24, 2017 | Not classified | Cincinnati District Office | |
| October 13, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for AtriCure, Inc.
- FDA Inspection 1077020 - 2018-12-13
- FDA Inspection 1043957 - 2018-03-09
- FDA Inspection 1042648 - 2017-10-05
- FDA Inspection 1045711 - 2017-08-24
- FDA Inspection 990475 - 2016-10-13
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