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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.
Classification Namecatheter, coronary, atherectomy
Generic Namecatheter
PMA NumberP980037
Supplement NumberS009
Date Received05/19/2004
Decision Date06/22/2004
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the pump set (also called the pump set plus) which included: 1) modification to the pump outlet and inlet fittings; 2) changes to the depth of the check ball seat and elimination of the check ball spring; 3) changes to the prime sensor cup; 4) changes to the piston head; 5) color changes to the luer; and 6) changes to the paratubing assembly.