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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 Name(R) QUANTUM MONORAIL(TM) PTCA CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheter
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP860019
Supplement NumberS167
Date Received11/17/2000
Decision Date01/11/2001
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the boston scientific scimed quantum monorail percutaneous transluminal coronary angioplasty (ptca) catheter (9, 12, 15, 18, and 20 mm lengths with balloon diameters of 2. 5 - 4. 0 mm in 1/4 mm increments). The quantum monorail ptca catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The quantum monorail ptca catheter (2. 5 - 4. 0 mm balloon diameters) is also indicated for the post-delivery expansion of balloon expandable stents.
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