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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLATITUDE PATIENT MANAGEMENT SYSTEM SOFTWARE
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator (non-crt)
Applicant
BOSTON SCIENTIFIC
4100 hamline avenue north
st. paul, MN 55112
PMA NumberP910077
Supplement NumberS071
Date Received01/16/2007
Decision Date03/28/2007
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE LATITUDE SYSTEM SOFTWARE, VERSION 2.1 (MODEL 6488) THAT CONTAINS REGULATED APPLICATION SERVER (RAS) SOFTWARE, VERSION 2.1.1 AND WEB APPLICATION SERVER (WAS) SOFTWARE, VERSION 2.1.1.
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