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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 NameADANTE PTCA CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheter
Regulation Number870.5100
ApplicantSCIMED LIFE SYSTEMS, INC.
PMA NumberP860019
Supplement NumberS154
Date Received03/15/1999
Decision Date04/05/1999
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the adante(tm) percutaneous transluminal coronary angioplasty (ptca) catheter (20 mm length with balloon diameters of 1. 5 mm, and 2. 0 -4. 0 mm in 1/4 mm increments, and 30 and 40 mm lengths with balloon diameters of 2. 0 - 4. 0 mm in 1/4 mm increments). The adante(tm) ptca catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocaridal perfusion. The adante(tm) ptca catheter (balloon models 2. 5 - 4. 0 mm in diameter) is also indicated for the post-delivery expansion of balloon expandable stents.
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