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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 NameSWEET TIP RX STEROID ELUTING LEAD
Classification Namepermanent pacemaker electrode
Generic Nameendocardial lead stabilizer (suture sleeve)
Regulation Number870.3680
ApplicantGUIDANT CORP.
PMA NumberP960006
Supplement NumberS004
Date Received08/21/2000
Decision Date09/25/2000
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: packager
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at an alternate facility for sterilization, packaging and labeling at guidant puerto rico, dorado, puerto rico.
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