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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 NumberS008
Date Received08/16/2001
Decision Date02/20/2002
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 for the micro-pace model 4580. The device is indicated for "any clinical situation in which the use of temporary pacemaker on a patient provides therapeutic or diagnostic value, or serves a prophylactic purpose. Specifically, indications for temporary pacemakers include, but are not limited to, the following: intermittent or complete heart block associated with asystole or bradycardia, symptomatic sinus bradycardia, surgically-induced heart block and heart block accompanying an acute myocardial infarction. Additionally, temporary cardiac pacing has been used to overdrive and thereby terminate atrial arrhythmias, including atrial flutter. It has been used in preparation for permanent pacemaker implantation to ascertain the thresholds for sensing and pacing on the acute lead system. ".