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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 SYSTEM
Generic NamePulse generator, permanent, implantable
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP910023
Supplement NumberS131
Date Received02/21/2007
Decision Date04/17/2007
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE ST. JUDE MEDICAL HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM, MERLIN.NET V2.0, WHICH WILL ALLOW THE PHYSICIAN TO VIEW CURRENTLY AVAILABLE WEB PORTAL. IN ADDITION, THE RECEIVER SOFTWARE HAS BEEN MODIFIED TO IMPROVE THE COMMUNICATION EFFICIENCY.
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