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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 Nameatherectomy system
PMA NumberP910019
Supplement NumberS003
Date Received10/28/1997
Decision Date01/29/1998
Product Code
MCX[ Registered Establishments with MCX ]
Docket Number N
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the 5. 5f tec(r) cutter catheter, involving an increase in the skirt length of the cutter component from 0. 079 inches to 0. 104 inches.