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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.
 
Trade NamePACESETTER MODEL 3070 & PACE MEDICAL MODEL 4553
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namedual chamber, implantable pulse generator
ApplicantPACESETTER SYSTEMS
PMA NumberP830045
Supplement NumberS032
Date Received03/29/1991
Decision Date01/11/1993
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for relocating the manufacturing facilities to 15900 valleyview court, sylmar, ca. , 91392-9221.
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