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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 Namerotational angioplasty system guide wires
PMA NumberP900056
Supplement NumberS037
Date Received02/04/2000
Decision Date03/08/2000
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add an additional step to the inspection procedure of the insert hub to confirm that the depth of the grooves are within specification.