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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 NameROTAWIRE FLOPPY GOLD GUIDE WIRE/ROTABLATOR SYSTEMS GUIDE WIRE LINE
Classification Namecatheter, coronary, atherectomy
Generic Namerotational angioplasty system guide wires
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP900056
Supplement NumberS022
Date Received11/07/1997
Decision Date08/06/1998
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 rotawire(tm) floppy gold guide wire for use with the rotablator(r) rotational angioplasty system.
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