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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 NameANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM
Classification Namecatheter, coronary, atherectomy
Generic Namecatheter
ApplicantMEDRAD INTERVENTIONAL/POSSIS
PMA NumberP980037
Supplement NumberS029
Date Received02/06/2009
Decision Date02/27/2009
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modification to the allowable combinations of medrad interventional/ possis (mip) products that may be sterilized with an ethylene oxide (eo) sterilization cycle.
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