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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.
 
Trade NameSIMPSON CORONARY ATHEROCATH-SCA-EX, GTO AND BANTAM ATHERECTOMY CATHETERS
Classification Namecatheter, coronary, atherectomy
Generic Nameptca
ApplicantGUIDANT CORP.
PMA NumberP890043
Supplement NumberS033
Date Received12/23/1998
Decision Date09/30/1999
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the labeling for the simpson coronary atherocath(r) sca-ex(tm), gto(r), and bantam(tm) atherectomy catheters to 1) include clinical data from the balloon versus optimal atherectomy trial (boat) and 2) streamline the remainder of the text.
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