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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-T TRANSMITTER AND MODEL 3180-R RECEIVER SOFTWARE (VERS
Classification Nameimplantable pacemaker pulse-generator
Generic Nametranstelephonic follow-up/monitoring system
Regulation Number870.3610
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP910023
Supplement NumberS073
Date Received04/15/2004
Decision Date05/12/2004
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 software modifications to the st. Jude medical housecall plus receiver software (version 2. 0) which also includes the support for the st. Jude medical epic and atlas icd families.
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