FDA Inspection
AtriCure, Inc.AtriCure, Inc. – FDA Inspection, Aug 29, 2016
Record Details
This FDA Inspection record concerns AtriCure, Inc., with an inspection on August 29, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- AtriCure, Inc.
- Inspection Date
- August 29, 2016
- Product Type
- Devices
View Company Profile
ID · 5dfceaac-c265-4bbd-8a60-9ebd2f345c6d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 990228
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
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 | VAI | 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 |
Other documents for AtriCure, Inc.
- FDA Inspection 1077020 - 2018-12-13
- FDA Inspection 1055553 - 2018-03-09
- FDA Inspection 1043957 - 2018-03-09
- FDA Inspection 1042648 - 2017-10-05
- FDA Inspection 1045711 - 2017-08-24
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