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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 FAMILY (INCLUDES SELUTE, SELUTE PICOTIP)
Classification Namepermanent pacemaker electrode
Generic Namealternate endocardial lead stabilizer component
Regulation Number870.3680
ApplicantGUIDANT CORP.
PMA NumberP950001
Supplement NumberS014
Date Received02/24/2005
Decision Date03/24/2005
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Change to the procedure for inspections of leads with drug subassemblies.
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