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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 NameROTAGLIDE(TM) LUBRICANT
Classification Namecatheter, coronary, atherectomy
Generic Namerotational angioplasty system guide wires
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP900056
Supplement NumberS045
Date Received05/18/2000
Decision Date06/06/2000
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes in the manufacturing process, removing one of the steps from the release criteria for rotaglide(tm) lubricant, to move the packaging inspection and review of the certificate of analysis from boston scientific corp. Northwest to boston scientific corp's marina bay distribution center in quincy, massechusetts.
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