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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 NameFLEXTEND BIPOLAR, STEROID ELUTING, EXTENDABLE/ RETRACTABLE PACING LEAD
Classification Namepermanent pacemaker electrode
Generic Nametransvenous bipolar pacing lead
Regulation Number870.3680
ApplicantGUIDANT CORP.
PMA NumberP960006
Supplement NumberS008
Date Received03/20/2003
Decision Date05/30/2003
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for change in the durometer hardness from 55d to 70d.
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