FDA Inspection
Medtronic Ablation FrontiersMedtronic Ablation Frontiers – FDA Inspection, May 16, 2011
Record Details
This FDA Inspection record concerns Medtronic Ablation Frontiers, with an inspection on May 16, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medtronic Ablation Frontiers
- Inspection Date
- May 16, 2011
- Product Type
- Devices
View Company Profile
ID · 7ea445c2-c395-4a2f-b58a-01e5c203277d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 727034
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 812.40Sponsors" general responsibilities
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medtronic Ablation Frontiers
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 29, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 6, 2011 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| June 11, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medtronic Ablation Frontiers
- FDA Inspection 843064 - 2013-07-29
- FDA Inspection 705228 - 2011-01-06
- FDA Inspection 669101 - 2010-06-11
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.