Company
United StatesMedtronic Ablation Frontiers, Carlsbad, CA – FDA Inspections
Inspection records and compliance data for Medtronic Ablation Frontiers in Carlsbad, California. 4 FDA inspections on record, last inspected July 29, 2013.
Company Profile
This profile covers Medtronic Ablation Frontiers based in Carlsbad, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected June 11, 2010. Last inspected July 29, 2013.
Most cited issue areas
- Sponsors" general responsibilities2 inspections
- No evaluation of unanticipated adverse effects1 inspection
- Sponsor correspondence records inadequate1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 29, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 843064 |
| May 16, 2011 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 727034 |
| January 6, 2011 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 705228 |
| June 11, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 669101 |
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 Ablation Frontiers
FEI Number
3007798852
Address
2210 Faraday Ave Ste 100, Carlsbad, California 92008, United States
Country
United States
ID: ed38b7e0-f93a-48a4-ab84-80ec9575de31