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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.
 
Trade NameMICROSOFTRAC TM (PTCA) CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC
PMA NumberP880027
Date Received04/07/1988
Decision Date04/14/1989
Withdrawal Date 04/13/2007
Product Code
LOX[ Registered Establishments with LOX ]
Docket Number 89M-0143
Notice Date 05/19/1989
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 S025 S026 S027 
S028 S029 S030 S031 S032 S033 S034 S035 S036 
S037 S038 S039 S040 S042 S043 S044 S048 S049 
S050 S051 S052 S053 S054 S055 S056 S057 S058 
S059 S060 S061 S062 S063 S064 
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