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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.
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
parkmore business park west
PMA NumberP790017
Supplement NumberS074
Date Received09/14/2000
Decision Date01/08/2001
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason other report
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of six (6) catalogue items to the approved d114s over-the-wire balloon dilatation catheter product line. These six items consist of a 10 mm balloon length in each of the current balloon diameters of 1. 5 mm, 2. 0 mm, 2. 5 mm, 3. 0 mm, 3. 5 mm, and 4. 0 mm. In addition, approval for a minor dimensional change to the 1. 5 mm diameter extruded balloon tubing (0. 0135"/0. 0205" id/od from the current 0. 014"/0. 022" id/od. The device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.