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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 NameSMARTVIEW REMOTE MONITORING SYSTEM: SMARTVIEW MONITOR PSTN MODEL, GPRS MODEL
Classification Namedefibrillator, implantable, dual-chamber
Generic Nameimplantable cardioverter-defibrillator with active housing
ApplicantSORIN GROUP CRM USA, INC
PMA NumberP980049
Supplement NumberS085
Date Received08/21/2013
Decision Date03/06/2014
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
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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