FDA Inspection
Atrium Medical CorporationAtrium Medical Corporation – FDA Inspection, Feb 10, 2020
Record Details
This FDA Inspection record concerns Atrium Medical Corporation, with an inspection on February 10, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Atrium Medical Corporation
- Inspection Date
- February 10, 2020
- Product Type
- Devices
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ID · d430ce7d-a4fc-4f0a-934a-b8e66344542f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1117399
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
Other FDA inspections of Atrium Medical Corporation
10| Date | Classification | Office | Project area |
|---|---|---|---|
| June 1, 2026 | Not classified | New England District Office | Postmarket Assurance: Devices |
| November 26, 2024 | NAI | New England District Office | Postmarket Assurance: Medical Devices |
| September 6, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 2, 2018 | OAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
| July 13, 2016 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Atrium Medical Corporation
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