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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 CONTRACT STERILIZER
Classification Namecatheter, coronary, atherectomy
Generic Namerotational angioplasty system guide wires
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP900056
Supplement NumberS023
Date Received01/30/1998
Decision Date02/23/1998
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change in location pilot
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate contract sterilizer at griffith micro science, new york facility, 84 park road, queensbury, ny 12804.
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