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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 NameROTATIONAL ANGIOPLASTY SYSTEM WITH ROTALINK PLUS EXCHANGEABLE CATHETER/ADVANCER
Classification Namecatheter, coronary, atherectomy
Generic Namerotational angioplasty system guide wires
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP900056
Supplement NumberS056
Date Received09/29/2000
Decision Date10/24/2000
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 additional manufacturing site located at boston scientific cork ltd. , cork, ireland and an additional sterilization facility located at isotron ireland ltd. , offaly, ireland.
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