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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 CONSULT SYSTEM
Classification Namepacemaker/icd/crt non-implanted components
Generic Nameimplantable cardioverter defibrillator systems
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP910077
Supplement NumberS147
Date Received09/05/2014
Decision Date11/06/2014
Product Code
OSR[ Registered Establishments with OSR ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the latitude consult system release 1. 01 which includes the communicator model 6299 and application software server model 6294.
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