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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 NameACS OTW PHOTON CORONARY DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namepercutaneous transluminal coronary angioplasty balloon dilatation catheter
Regulation Number870.5100
ApplicantGUIDANT CORP.
PMA NumberP810046
Supplement NumberS198
Date Received03/19/1999
Decision Date06/04/1999
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The device 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; 2) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction.
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