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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 NameFINELINE II/THINLINE II BRADY LEADS
Classification Namedrug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Generic Nameactive fixation transvenous bipolar pacing lead
ApplicantGUIDANT CORP.
PMA NumberP960004
Supplement NumberS042
Date Received12/08/2008
Decision Date06/05/2009
Product Code
NVN[ Registered Establishments with NVN ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a new supplier, optinova, and changes in specifications for foreign matter, gels, and bubbles for the polyurethane tubing lead body used in the device.
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