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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
ApplicantPOSSIS MEDICAL, INC.
PMA NumberP980037
Supplement NumberS006
Date Received12/18/2002
Decision Date01/14/2003
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification to the manufacturing procedures for mounting of the hardware to the drive unit control board (i. E. , implementation of a minimum torque requirement).
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