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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 MULTI-LINK TM CORONARY STENT SYSTEM WITH THE 25MM STENT LENGTH
ApplicantGUIDANT CORP.
PMA NumberP970020
Supplement NumberS001
Date Received02/03/1998
Decision Date08/04/1998
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for acs rx multi-link hp(tm) coronary stent system with the 25 mm stent length.
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