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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,SELUTE PICOTIP
Classification Namepermanent pacemaker electrode
Generic Namealternate endocardial lead stabilizer component
Regulation Number870.3680
ApplicantGUIDANT CORP.
PMA NumberP950001
Supplement NumberS012
Date Received10/21/2004
Decision Date11/19/2004
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 procedures for inspections of materials/ components received from suppliers.
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