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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 NameMODEL 3140 ZOOM WIRELESS TRANSMITTER AND MODEL 3120 ZOOM LATITUDE PROGRAMMER/RECORDER/MONITOR (PRM)
Classification Namepacemaker/icd/crt non-implanted components
Generic Nameimplantable cardioverter defibrillator systems
ApplicantBOSTON SCIENTIFIC CORPORATION
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 - specifications
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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