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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.
 
DeviceZOOM LATITUDE PROGRAMMING SYSTEM
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 NumberS134
Date Received05/17/2013
Decision Date06/20/2013
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 USE OF AN ALTERNATE ANTENNA (MODEL 3123) WITH THE LATITUDE PROGRAMMER/RECORDER/MONITOR MODEL 3120 AND ASSOCIATED DEVICE LABELING.
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