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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 MULTI-LINK HP/ACS OTW MULTI LINK HP CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Nameintravascular coronary stent
ApplicantGUIDANT CORP.
PMA NumberP970020
Supplement NumberS003
Date Received05/11/1998
Decision Date11/24/1998
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the mean stent compliance outer diameter specification, associated with the acs rx multi-link hp(tm) and acs otw multi-link hp(tm) coronary stents systems.
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