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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 NameSCIMED NC MAXXUM PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Name catheter
Regulation Number870.5100
ApplicantSCIMED LIFE SYSTEMS, INC.
PMA NumberP860019
Supplement NumberS150
Date Received10/05/1998
Decision Date04/08/1999
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the scimed nc maxxum(tm) ptca catheter (20mm balloon length with balloon diameters of 2. 0mm, 2. 5-4. 0mm in 1/4mm increments and 4. 5mm, -5. 0mm in 1/2mm increments; and 9mm and 15mm lengths with balloon diameterrs of 2. 5-4. 0mm in 1/4mm increments and 4. 5mm - 5. 0mm) in 1/2mm increments. The nc maxxum(tm) ptca catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or byapss graft stenosis for th epurpose of improving myocardial perfusion. The nc maxuum(tm) ptca catheter (balloon models 2. 5-4. 0mm in diameter) is also indicated for the post-delivery expansion of balloon expandable stents.
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