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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.
 
DevicePARADYM RF VR ICDS
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantMicroPort CRM USA Inc.
5640 Airline Road
Arlington, TN 38002
PMA NumberP980049
Supplement NumberS071
Date Received03/13/2012
Decision Date05/09/2013
Product Code MRM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE SMARTVIEW HOME MONITOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SMARTVIEW HOME MONITOR AND IS INDICATED FOR USE WITH SORIN RADIO FREQUENCY IMPLANTED CARDIAC DEVICE ONLY AND ANY HOUSEHOLD TRADITIONAL (ANALOG TYPE) TELEPHONE LAND LINE; IT WILL NOT OPERATE WITH OTHER LINES SUCH AS AND NOT LIMITED TO DIGITAL, DSL OR OPTICAL FOR THE PSTN DEVICE AND THE SMARTVIEW MONITOR IS DESIGNED FOR USE WITH THE SORIN RADIO FREQUENCY IMPLANTED CARDIAC DEVICE ONLY FOR GPRS DEVICES.
Approval OrderApproval Order
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