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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
Classification Namepermanent pacemaker electrode
Generic Nameimplantable endocardial pacemaker lead
Regulation Number870.3680
ApplicantSULZER INTERMEDICS, INC.
PMA NumberP960004
Supplement NumberS005
Date Received06/14/1999
Decision Date07/01/1999
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the thinline(tm) pacing leads under the guidant fineline(tm) trade name. These devices are indicated for permanent pacing and sensing in the ventricle and/or the atrium when used with a compatible pulse generator.
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