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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namecatheter, coronary, atherectomy
Generic Nameatherectomy device
PMA NumberP890043
Date Received08/18/1989
Decision Date09/14/1990
Withdrawal Date 09/05/2014
Product Code
MCX[ Registered Establishments with MCX ]
Docket Number 90M-0318
Notice Date 10/19/1990
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S011 S012 S013 S014 S015 S016 S017 S020 S021 
S022 S025 S026 S027 S028 S030 S031 S032 S033 
S034 S035 S037 S038 S039