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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NamePROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameav implantable programable cardiac pacing system
ApplicantPACESETTER SYSTEMS
PMA NumberP820023
Date Received04/12/1982
Decision Date02/04/1983
Withdrawal Date 03/13/1989
Product Code
LWP[ Registered Establishments with LWP ]
Docket Number 83M-0048
Notice Date 02/25/1983
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S002 S003 S004 S005 
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