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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceROTAWIRE FLOPPY GOLD GUIDE WIRE/ROTABLATOR SYSTEMS GUIDE WIRE LINE
Classification Namecatheter, coronary, atherectomy
Generic Namecatheter, coronary, atherectomy
Applicant
Boston Scientific Corp.
two scimed place
maple grove, MN 55311-1566
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/material
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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