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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-T TRANSMITTER (SOFTWARE VERSION 1.1) AND MODEL 3180-R
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
Applicant
St. Jude Medical
15900 valley view ct.
sylmar, CA 91342-3577
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/material
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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