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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicePROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantPACESETTER SYSTEMS
12884 BRADLEY AVE.
SYLMAR, CA 91342
PMA NumberP820023
Date Received04/12/1982
Decision Date02/04/1983
Withdrawal Date 03/13/1989
Product Code LWP 
Docket Number 83M-0048
Notice Date 02/25/1983
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Supplements:  S002 S003 S004 S005 
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