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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 NamePOSSIS ANGIOJET(R) RHEOLYTIC(TM) THROMBECTOMY SYSTEM - CORONARY USE
Classification Namecatheter, coronary, atherectomy
Generic Namepercutaneous coronary thrombectomy catheter
ApplicantPOSSIS MEDICAL, INC.
PMA NumberP980037
Supplement NumberS002
Date Received02/29/2000
Decision Date03/17/2000
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the additiion of a label to the current inventory of the lf 140 catheter which reads "caution: do not inject fluids in catheter outflow lumen".
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