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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
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP900056
Supplement NumberS084
Date Received04/25/2005
Decision Date05/25/2005
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an additional quality control (qc) inspection method using the passage of guidewire through the rotalink plus device lumen to verify the device is free from obstructions.
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