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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.
Classification Namepermanent pacemaker electrode
Generic Nameimplantable endocardial pacemaker lead
Regulation Number870.3680
PMA NumberP960004
Supplement NumberS008
Date Received08/31/1999
Decision Date09/27/1999
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the alternate manufacturing facility located at guidant puerto rico, no. 12 road no. 698, dorado, puerto rico 00646 and the alternate sterilization facility located at cosmed of illinois, 1160 northpoint blvd. , waukegan, illinois 60085.