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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 PHEOLYTIC THROMBECTOMY SYSTEM
Classification Namecatheter, coronary, atherectomy
Generic Namecatheter
ApplicantPOSSIS MEDICAL, INC.
PMA NumberP980037
Supplement NumberS010
Date Received05/19/2004
Decision Date06/22/2004
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the packaging specifically to the inner tray and outer pouch.
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