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St. Jude Medical, Atrial Fibrillation Division, Inc.

✅ Low Risk

FEI: 1000139754 • Saint Paul, MN • UNITED STATES

FEI

FEI Number

1000139754

📍

Location

Saint Paul, MN

🇺🇸
🏢

Address

1 Saint Jude Medical Dr, , Saint Paul, MN, United States

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
7/8/2010
Latest Refusal
7/8/2010
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
7/8/2010
80LDQDEVICE, GENERAL MEDICAL
118NOT LISTED
New York District Office (NYK-DO)

Frequently Asked Questions

What is St. Jude Medical, Atrial Fibrillation Division, Inc.'s FDA import refusal history?

St. Jude Medical, Atrial Fibrillation Division, Inc. (FEI: 1000139754) has 1 FDA import refusal record(s) in our database, spanning from 7/8/2010 to 7/8/2010.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. St. Jude Medical, Atrial Fibrillation Division, Inc.'s FEI number is 1000139754.

What types of violations has St. Jude Medical, Atrial Fibrillation Division, Inc. received?

St. Jude Medical, Atrial Fibrillation Division, Inc. has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about St. Jude Medical, Atrial Fibrillation Division, Inc. come from?

All FDA import refusal data for St. Jude Medical, Atrial Fibrillation Division, Inc. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.