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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 NameACUITY SPIRAL, EASYTRAK 2 LV-1, EASYTRAK 2 IS-1, EASYTRAK 3 LV-1, EASYTRAK 3 IS-1
Classification Nameimplantable pulse generator, pacemaker (non-crt)
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP010012
Supplement NumberS365
Date Received07/25/2014
Decision Date08/15/2014
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Removal of the 36-month shelf life for polyurethane tubing.
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