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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 NamePARAGON II AND PHOENIX PULSE GENERATORS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namedual chamber, implantable pulse generator
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PMA NumberP830045
Supplement NumberS060
Date Received09/09/1998
Decision Date10/15/1998
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested approval for use of parametric release as an alternate to the current use of biological indicators in the release of sterilized products.
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