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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.
 
DeviceEASYTRAK 3 IS-1 LEADS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
Boston Scientific Corp.
4100 hamline ave north
st. paul, MN 55112
PMA NumberP010012
Supplement NumberS274
Date Received12/02/2011
Decision Date03/05/2012
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the following changes: 1) addition of optinova as supplier of extruded polyurethane tubing; 2) modification to dimensional tolerances for extruded polyurethane tubing; 3) modification to polyurethane tubing specification for foreign material, bubbles, and gel inclusions; and 4) removal of redundant methylene dianiline (mda) residual level requirements for extruded tubing,.
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