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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 NameSELUTE AND SELUTE PICOTIP
Classification Namepermanent pacemaker electrode
Generic Namealternate endocardial lead stabilizer component
Regulation Number870.3680
ApplicantGUIDANT CORP.
PMA NumberP950001
Supplement NumberS015
Date Received10/07/2005
Decision Date11/15/2005
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval to extend the shelf life of the drug plug component of the leads from one year to three years. The shelf life of the finished leads remains two years.
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