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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 NumberS030
Date Received10/20/1999
Decision Date12/02/1999
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason pas protocal supplement ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to existing related quality assurance inspections, manufacturing changes, and labeling changes, which are being implemented to correct a brake mechanism failure problem.