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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 NameCOSMOS/NOVA/QUANTUM/SUPRIMA/PULSE GENERATORS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namedual chamber, implantable pulse generator
ApplicantSULZER INTERMEDICS, INC.
PMA NumberP830026
Supplement NumberS067
Date Received03/08/1996
Decision Date08/19/1996
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of an alternate conductive epoxy and a production process change for automated application of this epoxy in the manufacture of implantable pulse generators.
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