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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 CORONARY DILATATION CATHETERS (INDICATION)
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecoronary balloon dilatation catheter
Regulation Number870.5100
ApplicantGUIDANT CORP.
PMA NumberP810046
Supplement NumberS170
Date Received11/25/1996
Decision Date05/13/1997
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
Approval for: a) the addition of the indication "balloon dilatation of a coronary artery occlusion ofr the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction"; and (b) other modifications ot the current label to reflect this new indication.
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