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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.
 
DeviceSMARTVIEW REMOTE MONITORING SYSTEM: SMARTVIEW MONITOR PSTN MODEL, GPRS MODEL
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantMicroPort CRM S.r.l.
Via Crescentino S.N.
Saluggia 13040
PMA NumberP980049
Supplement NumberS085
Date Received08/21/2013
Decision Date03/06/2014
Product Code MRM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR:1) A FIRMWARE PATCH FOR THE IMPLANTABLE DEVICE WITH THE MICROPROCESSOR (UP) V4B; 2) A NEW FIRMWARE VERSION FOR THE UP V4C AND V4D; 3) THE HARDWARE MODIFICATIONS FOR THE IMPLANTABLE DEVICES; 4) THE UPDATES/ MODIFICATIONS FOR THE PROGRAMMER APPLICATION SOFTWARE; AND 5) THE UPDATES/ MODIFICATIONS FOR THE REMOTE MONITORING SYSTEM (RMS).
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