FDA Inspection
St. Jude Medical, Atrial Fibrillation Division, Inc.St. Jude Medical, Atrial Fibrillation Division, Inc. – FDA Inspection, Mar 29, 2019
Record Details
This FDA Inspection record concerns St. Jude Medical, Atrial Fibrillation Division, Inc., with an inspection on March 29, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 29, 2019
- Product Type
- Devices
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ID · be1c588d-53a9-428d-a5b9-05c70f3fbed5
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1084607
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
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Other FDA inspections of St. Jude Medical, Atrial Fibrillation Division, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 17, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| September 28, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 27, 2017 | Not classified | Minneapolis District Office |
Other documents for St. Jude Medical, Atrial Fibrillation Division, Inc.
- FDA Inspection 1053126 - 2018-05-17
- FDA Inspection 1029059 - 2017-09-28
- FDA Inspection 1034622 - 2017-07-27
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