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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
26531 ynez rd.
temecula, CA 92591
PMA NumberP810046
Supplement NumberS204
Date Received10/20/2000
Decision Date03/02/2001
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for new catheter models. The devices, as modified will be marketed under the trade names powersail(tm) and highsail(tm) coronary dilatation catheters and are 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. 3) balloon dilatation of the acs multi-link(tm), acs multi-link(tm), acs multi-link duet(tm), acs multi-link tristar(tm), multi-link tetra(tm) or acs multi-link ultra(tm) stents after implantation.