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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.
 
DeviceTHINLINE II/FINELINE II STEROX PACING LEADS
Generic Namepermanent pacemaker Electrode
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP960004
Supplement NumberS018
Date Received02/20/2001
Decision Date04/06/2001
Product Codes DTB DXY 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE USE OF MANNITOL AS AN ALTERNATE MATERIAL TO COVER THE HELIX ON THE ABOVE REFERENCED ACTIVE FIXATION PACING LEADS. THE DEVICES ARE INDICATED FOR PERMANENT PACING AND SENSING OF THE ATRIUM AND/OR VENTRICLE WHEN USED WITH A COMPATIBLE PULSE GENERATOR.
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