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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 PATIENT MANAGEMENT SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator systems
ApplicantBOSTON SCIENTIFIC CORPORATION (BSC)
PMA NumberP910077
Supplement NumberS097
Date Received09/30/2009
Decision Date11/25/2009
Product Code
LWS[ Registered Establishments with LWS ]
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 changes to the latitude patient management system g2 rf communicator model 6476 software, version 3. 02 and latitude patient management server model 6488, version 5. 2.
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