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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 PATIENT MANAGEMENT SYSTEM, LATITUDE NXT RELEASE 3.0
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator systems
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP910077
Supplement NumberS143
Date Received05/27/2014
Decision Date07/16/2014
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the wave communicator model 6280 sw version v1. 52. 00; wave communicator model 6290 sw version v2. 02. 00; wave communicator model 6498 sw version v1. 52. 00; latitude nxt system software model 6460 v. 3. 00. 01; and communicator accessory and literature kit model 6250.
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