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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 NameLATITUDE NXT 2.0 PATIENT MANAGEMENT SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator systems
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP910077
Supplement NumberS140
Date Received11/21/2013
Decision Date06/20/2014
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the latitude nxt 2. 0 software for the wave communicator model 6460, changes to the wave communicator 6280, approval of the wave communicator 6290, and updates to the communication software for wave communicator models 6498 and 6476.
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