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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
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
Supplement NumberS005
Date Received11/03/1983
Decision Date02/23/1984
Withdrawal Date03/13/1989
Product Code LWP 
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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