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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.
 
DeviceACS RX ESPRIT
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
26531 ynez rd.
temecula, CA 92591
PMA NumberP810046
Supplement NumberS177
Date Received04/21/1997
Decision Date09/19/1997
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 the acs rx esprit(tm) coronary dilatation catheter. The device is indicated for: 1)balloon dilatation fo the stenotic portion of a coronary artery or bypass draft stenosis for the purpose of improving myocardial perfusion; and 2)balloon dilatation of a coronary artery occlusion ofr the purpose of restoring coronary flow in patients iwth s-t segment elevation myocardial infarction.
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