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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 NumberS028
Date Received06/23/1999
Decision Date08/09/1999
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested the use of alternate biological indicators with a reduced incubation time.
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