Medtronic International Trading Sarl
⚠️ Moderate Risk
FEI: 3002807576 • Tolochenaz, Vaud • SWITZERLAND
FEI Number
3002807576
Location
Tolochenaz, Vaud
Country
SWITZERLANDAddress
Case Postale, Route Du Molliau 31, Tolochenaz, Vaud, Switzerland
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 PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.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 |
|---|---|---|---|
| 3/5/2005 | 74DROPACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) | 2380NO PMA/PDP | Los Angeles District Office (LOS-DO) |
| 3/5/2005 | 74DROPACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/5/2005 | 74DROPACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) | 237NO PMA | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Medtronic International Trading Sarl's FDA import refusal history?
Medtronic International Trading Sarl (FEI: 3002807576) has 3 FDA import refusal record(s) in our database, spanning from 3/5/2005 to 3/5/2005.
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. Medtronic International Trading Sarl's FEI number is 3002807576.
What types of violations has Medtronic International Trading Sarl received?
Medtronic International Trading Sarl 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 Medtronic International Trading Sarl come from?
All FDA import refusal data for Medtronic International Trading Sarl 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.