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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 (SOFTWARE VERSION 1.1) AND MODEL 3180-R
Classification Nameimplantable pacemaker pulse-generator
Generic Nametiered therapy implantable defibrillator
Regulation Number870.3610
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP910023
Supplement NumberS071
Date Received10/07/2003
Decision Date11/06/2003
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the housecall 2. 0 system. The device, as modified, will be marketed under the trade name housecall plus transtelephonic monitoring system and is indicated as follows: the housecall plus system is indicated for use in performing remote follow-up monitoring on patients having the following st. Jude medical cardioverter/ defribrillators: atlas dr model v-240, atlas vr model v-199, epic+ dr model v-236, epic+ vr model v-1961, epic dr model v-235 and epic vr model v-197.
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