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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 NameRX CHASSIS 3 CORONARY DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namepercutaneous transluminal coronary angioplasty balloon dilatation catheter
Regulation Number870.5100
ApplicantABBOTT VASCULAR-CARDIAC THERAPIES
PMA NumberP810046
Supplement NumberS215
Date Received01/26/2004
Decision Date07/16/2004
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the rx chassis 3 coronary dilation catheter. The device, as modified, is indicated for 1) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, and 2) balloon dilatation of a coronary occlusion for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction.
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