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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 NameZOOM LATITUDE PROGRAMMER
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator systems
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP910077
Supplement NumberS136
Date Received07/22/2013
Decision Date08/21/2013
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Alternate supplier for the off-the-shelf flash memory chip to be used on the input/output (i/o) printed circuit assembly (pca) of the device.
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