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•United States

LivaNova USA Inc., Arvada, CO – FDA Inspections

Inspection records and compliance data for LivaNova USA Inc. in Arvada, Colorado. 4 FDA inspections on record, last inspected March 30, 2016.

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Company Profile

This profile covers LivaNova USA Inc. based in Arvada, Colorado, United States.

FDA Inspection History

FDA inspections
4
OAI
0
VAI
1
NAI
3
Form 483s
0
Warning letters
0

First inspected July 14, 2009. Last inspected March 30, 2016.

FDA inspections (4)

DateResultFDA center(s)Insp. #
March 30, 2016NAIMedical Devices & Rad Health · Postmarket Assurance: Devices970724
September 1, 2015NAIMedical Devices & Rad Health · Postmarket Assurance: Devices944258
March 26, 2013VAIMedical Devices & Rad Health · Compliance: Devices824401
July 14, 2009NAIMedical Devices & Rad Health · Compliance: Devices598390
FDA documents

Form 483s (4)

  • Form 483s · September 1, 2015
  • Form 483s · March 26, 2013
  • Form 483s · July 14, 2009
  • Form 483s · July 25, 2008

EIRs (4)

  • EIRs · September 1, 2015
  • EIRs · March 26, 2013
  • EIRs · July 14, 2009
  • EIRs · July 25, 2008
People (1)
Amanda S. Zorn
Person
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Company Information

Name

LivaNova USA Inc.

FEI Number

1718850

Address

14401 W 65th Way, Arvada, Colorado 80004, United States

Country

United States

ID: 4c8872e9-2e3c-4048-b29d-a5b9ede8e969

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