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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameHOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-R RECEIVER SOFTWARE (VERSION 2.1)
Classification Nameimplantable pacemaker pulse-generator
Generic Nametranstelephonic follow-up/monitoring system
Regulation Number870.3610
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP910023
Supplement NumberS078
Date Received04/18/2005
Decision Date05/24/2005
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the software modifications to the st. Jude medical housecall plus receiver software (version 2. 1).
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