PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P

FDA Premarket Approval P820023

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.

Pre-market Approval Supplement Details

DevicePROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P
Generic NameImplantable Pulse Generator, Pacemaker (non-crt)
ApplicantPACESETTER SYSTEMS
Date Received1982-04-12
Decision Date1983-02-04
Notice Date1983-02-25
PMAP820023
SupplementS
Product CodeLWP 
Docket Number83M-0048
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address PACESETTER SYSTEMS 12884 Bradley Ave. sylmar, CA 91342

Supplemental Filings

Supplement NumberDateSupplement Type
P820023Original Filing
S005 1983-11-03
S004 1983-08-09
S003 1983-06-06
S002 1983-03-25
S001

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