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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, SWEET PICOTIP RX, FLEXTEND
Classification Namepermanent pacemaker electrode
Generic Nametransvenous bipolar pacing lead
Regulation Number870.3680
ApplicantGUIDANT CORP.
PMA NumberP960006
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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