Boston Scientific Corporation
⚠️ Moderate Risk
FEI: 2124215 • Saint Paul, MN • UNITED STATES
FEI Number
2124215
Location
Saint Paul, MN
Country
UNITED STATESAddress
4100 Hamline Ave N, , Saint Paul, MN, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/4/2014 | 74LWSDEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | 237NO PMA | New York District Office (NYK-DO) |
| 1/4/2011 | 74DRBSTYLET, CATHETER | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 9/1/2010 | 74JOOTRANSDUCER, HEART SOUND | 508NO 510(K) | Minneapolis District Office (MIN-DO) |
| 4/13/2005 | 74DXYPULSE-GENERATOR, PACEMAKER, IMPLANTABLE | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Boston Scientific Corporation's FDA import refusal history?
Boston Scientific Corporation (FEI: 2124215) has 4 FDA import refusal record(s) in our database, spanning from 4/13/2005 to 12/4/2014.
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. Boston Scientific Corporation's FEI number is 2124215.
What types of violations has Boston Scientific Corporation received?
Boston Scientific Corporation has been cited for 3 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 Boston Scientific Corporation come from?
All FDA import refusal data for Boston Scientific Corporation 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.