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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.
Classification Namepulse-generator, pacemaker, external
Generic Namepulse-generator, pacemaker, external
Regulation Number870.3600
391 totten pond rd.
waltham, MA 02451
PMA NumberP920032
Supplement NumberS006
Date Received01/18/2001
Decision Date04/06/2001
Product Code
DTE[ Registered Establishments with DTE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the temporary pacemakers by replacing the zener diodes used for protecting the internal electronics from high voltage transients with a transient voltage suppressor.