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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
26531 ynez rd.
temecula, CA 92591
PMA NumberP810046
Supplement NumberS185
Date Received01/20/1998
Decision Date06/08/1998
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an additional balloon length, the addition of HYDROCOAT(TM) hydrophilic coating, a change in the sterilization method and hydrophilic coating, a change in the sterilization method and hydrophilic coating, a change in the sterilization method and packaging and an increase in the rated ubrst pressure for the 3.25mm through 4.0mm balloon diameters. The device as modified, will be marketed under the trade name ACS RX Comet VP(TM) Coronary Dilatation Catheters with HYDROCOAT(TM) Hydrophilic coating and is indicated for: 1)balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improvng myocardial perfusion; and 2) balloon dilatation of a coronary artery occlusion for the purose of restoring coronary flow in patients with ST-segment elevation yocardial infarction.