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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 NameATHEROCATH-BANTAM(TM) DIRECTIONAL CORONARY ATHERECTOMY SYSTEM
Classification Namecatheter, coronary, atherectomy
Generic Nameptca
ApplicantGUIDANT CORP.
PMA NumberP890043
Supplement NumberS031
Date Received07/01/1996
Decision Date11/18/1996
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the atherocath-bantam(tm) dca system.
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