Boston Scientific
⚠️ Moderate Risk
FEI: 3006474343 • Sydney • AUSTRALIA
FEI Number
3006474343
Location
Sydney
Country
AUSTRALIAAddress
247 Coward St, , Sydney, , Australia
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
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).
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/14/2008 | 74LWPPULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | Los Angeles District Office (LOS-DO) | |
| 10/14/2008 | 74NIKDEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATION | Los Angeles District Office (LOS-DO) | |
| 10/14/2008 | 74LWOPULSE-GENERATOR, SINGLE CHAMBER, SENSOR DRIVEN, IMPLANTABLE | Los Angeles District Office (LOS-DO) | |
| 10/14/2008 | 74DXYPULSE-GENERATOR, PACEMAKER, IMPLANTABLE | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Boston Scientific's FDA import refusal history?
Boston Scientific (FEI: 3006474343) has 4 FDA import refusal record(s) in our database, spanning from 10/14/2008 to 10/14/2008.
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's FEI number is 3006474343.
What types of violations has Boston Scientific received?
Boston Scientific 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 come from?
All FDA import refusal data for Boston Scientific 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.