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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 NamePASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS
Classification Namepermanent pacemaker electrode
Generic Nameendocardial pacing leads
Regulation Number870.3680
ApplicantPACESETTER, INC.
PMA NumberP960030
Supplement NumberS003
Date Received09/15/1998
Decision Date10/15/1998
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested approval for use of parametric release as ana lternate to the current use of biological indicators in the releae of sterilized products.
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