FDA Inspection
Medtronic CryoCath LPMedtronic CryoCath LP – FDA Inspection, Oct 31, 2024
Record Details
This FDA Inspection record concerns Medtronic CryoCath LP, with an inspection on October 31, 2024, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · cda6c9c9-d42e-491a-a810-4bfd86739eb9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1253044
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
1- 21 CFR 820.86Acceptance status
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medtronic CryoCath LP
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 27, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 15, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 16, 2011 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| December 10, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Medtronic CryoCath LP
- FDA Inspection 992735 - 2016-10-27
- FDA Inspection 844849 - 2013-08-15
- FDA Inspection 761562 - 2011-12-16
- FDA Inspection 633459 - 2009-12-10
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