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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 STEROX LEADS
Classification Namepermanent pacemaker electrode
Generic Nameactive fixation transvenous bipolar pacing lead
Regulation Number870.3680
ApplicantGUIDANT CORP.
PMA NumberP960004
Supplement NumberS020
Date Received11/16/2001
Decision Date12/18/2001
Product Code
DTB[ Registered Establishments with DTB ]
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 use of dexamethasone acetate (dxa) as an alternate steroid collar on the fineline ii sterox lead models 4456, 4457, 4458, 4459, 4469, 4470, 4471, 4472, 4473, 4479 and 4480.
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