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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.
 
DeviceEASYTRAK 2+ IS-1 CORONARY VENOUS STEROID ELUTING DUAL ELECTRODE PACE/SENSE LEADS
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific Corp
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP010012
Supplement NumberS380
Date Received11/28/2014
Decision Date01/21/2015
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ADDITION OF SILGLIDE COATING TO THE OUTER DISTAL SILICONE BODY TUBING TO EASE DELIVERY THROUGH AN INNER CATHETER 7 FRENCH AND ASSOCIATED LABEL CHANGES TO REBRAND THE LEAD AS EASYTRAK 2+.
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