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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(R) ROTATIONAL ANGIOPLASTY SYSTEM
Classification Namecatheter, coronary, atherectomy
Generic Namerotational angioplasty system; atherectomy
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP900056
Supplement NumberS021
Date Received08/20/1997
Decision Date12/19/1997
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate manufacturing facility located at seamed corporation, 21621 30th avenue ne, bothell, wa 98021.
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