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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 RX ESPRIT
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecoronary dilatation catheter
Regulation Number870.5100
ApplicantGUIDANT CORP.
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 - other
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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