FDA WARNING_LETTER - Medtronic, Inc. - July 07, 2021

FDA WARNING_LETTER for Medtronic, Inc. on July 07, 2021. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Medtronic, Inc. on July 07, 2021. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 352(t)(2)

FD&C Act 518

21 CFR 820.100(a)

21 CFR 803.50(a)(1)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.198(c)

FD&C Act 519(g)

21 CFR 803.50(a)(2)

21 U.S.C. 351(h)

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Record Information

Company

Medtronic, Inc.

Inspection Date

July 7, 2021

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 57e1434c-6845-4325-a03f-d1b5eebdc5ed

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