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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 ROCKET TM AND ACS AVENGER CORONARY DILATATION CAHTETERS
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecoronary dilatation catheter
Regulation Number870.5100
ApplicantGUIDANT CORP.
PMA NumberP810046
Supplement NumberS179
Date Received06/19/1997
Decision Date11/07/1997
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 rocket(tm) and acs avenger(tm) coronary dilatation catheters. The device is indicated for: 1)balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for ht epurpose of improving myocardial perfusion; and 2) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with s-t segment elevation myocardial infarction.
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