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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 NameROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
Classification Namecatheter, coronary, atherectomy
Generic Namerotational angioplasty system guide wires
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP900056
Supplement NumberS046
Date Received05/19/2000
Decision Date06/13/2000
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Alternate vendor for the bake hypo tubes used in the manufacturing of the rotablator rotalink advancer and passivated at the vendor, an additional manufacturing step for the component.
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