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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.
 
DeviceMODEL 3140 ZOOM WIRELESS TRANSMITTER AND MODEL 3120 ZOOM LATITUDE PROGRAMMER/RECORDER/MONITOR (PRM)
Classification Namepacemaker/icd/crt non-implanted components
Generic Namepacemaker/icd/crt non-implanted components
Applicant
BOSTON SCIENTIFIC
4100 hamline avenue north
st. paul, MN 55112
PMA NumberP910077
Supplement NumberS139
Date Received09/30/2013
Decision Date04/11/2014
Product Code
OSR[ Registered Establishments with OSR ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
APPROVAL FOR THE FOLLOWING CHANGES:1) NEW PULSE GENERATOR MODELS LISTED ABOVE AND MODIFICATIONS TO THE MODEL 2868 PROGRAMMER APPLICATION SOFTWARE USED TO COMMUNICATE WITH THE NEW DEVICES AND EXISTING DEVICES; AND 2) MODEL 3140 ZOOM WIRELESS TRANSMITTER AND ASSOCIATED MODIFICATIONS TO THE MODEL 3120 PRM SOFTWARE.
Approval Order Approval Order
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