Company
United StatesMedtronic Vascular, Inc., Santa Rosa, CA – FDA Inspections
Inspection records and compliance data for Medtronic Vascular, Inc. in Santa Rosa, California. 5 FDA inspections on record, last inspected September 08, 2017.
Company Profile
This profile covers Medtronic Vascular, Inc. based in Santa Rosa, California, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected June 19, 2009. Last inspected September 8, 2017.
Most cited issue areas
- Investigation of device failures1 inspection
- Lack of or inadequate procedures1 inspection
- Reporting Information Reasonably Known1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 8, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1026763 |
| April 19, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 976758 |
| January 21, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 968311 |
| September 4, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 841494 |
| June 19, 2009 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 595178 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Medtronic Vascular, Inc.
FEI Number
3005364322
Address
3850 Brickway Blvd, Santa Rosa, California 95403, United States
Country
United States
ID: 9ea1f72c-f6bc-46cb-984b-0272e05bf68a