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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 NameIS-1 CONNECTOR TERMINAL OF SELUTE/PICOTIP BIPOLAR LEADS
Classification Namepermanent pacemaker electrode
Generic Namealternate endocardial lead stabilizer component
Regulation Number870.3680
ApplicantGUIDANT CORP.
PMA NumberP950001
Supplement NumberS006
Date Received04/17/2000
Decision Date05/19/2000
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 No
Approval Order Statement 
Approval for: 1) use of a new mechanically interlocking component design to connect the terminal pin to the terminal ring, and 2) use of a shorter is-1 connector terminal.
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