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PMA - Premarket Approval

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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(R)II,NOVA(R)II,QUANTUM(R)II, & RX2000(R)
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namedual chamber, implantable pulse generator
ApplicantINTERMEDICS, INC.
PMA NumberP830026
Supplement NumberS054
Date Received05/11/1992
Decision Date12/29/1992
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change - other
Expedited Review Granted? No
 
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