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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 WITH THE ROTALINK(TM)
Classification Namecatheter, coronary, atherectomy
Generic Namerotational angioplasty system; atherectomy
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP900056
Supplement NumberS018
Date Received06/20/1996
Decision Date02/13/1997
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the rotalink(tm) exchangeable catheter for the rotablator(r) rotational angioplasty system and is indicated for use in patients with coronary artery disease sho are candidates for coronary artery bypass graft (cabg) srugery and who meet one of the following criteria:single vessel atherosclerotic coronary artery disease with a stenosis that can be passed with a guide wire; multiple vessel coronary artery disease that in the physician's judgment does not pose undo risk to the patient; certain patients with previous ptca, and who have a restenosis of the native vessel; or native vessel atherosclerotic coronary artery disease that is less than 25 mm in length.
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