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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 NameD114S OTW BALLOON DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantMEDTRONIC IRELAND
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.
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