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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
ApplicantBAYER MEDICAL CARE INC.
PMA NumberP980037
Supplement NumberS041
Date Received02/03/2014
Decision Date03/05/2014
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 change the current manual method of quantifying the amount of bacterial endotoxins present to using an automated instrument. Additionally, the number of samples collected will be changed to three samples per sterile load, tested on a pooled basis and with explicit extraction instructions.
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