FDA-Device2019-02-13Class II

MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Hazard

The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. Prior to use, refer to the Programmer Reference Guide as well as the appropriate programmer software and implantable device technical manuals for more information related to specific implantable device models. Programming should be attempted only by appropriately trained personnel after careful study of the technical manual for the implantable device and after careful determination of appropriate parameter values based on the patient's condition and pacing system used. The Medtronic CareLink Encore 29901 programmer must be used only for programming implantable devices manufactured by Medtronic or Vitatron.

Sold states

US, Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, Syrian Arab Republic

Affected count

33007 units

Manufactured in

8200 Coral Sea St Ne, Mounds View, MN, United States

Products

MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0796-2019

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