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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.
 
DeviceADANTE PTCA CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
Applicant
SCIMED LIFE SYSTEMS, INC.
one scimed place
maple grove, MN 55311-1566
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 - indications/instructions/shelf life/tradename
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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