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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 RX DUET TM AND ACS MULTI-LINK OTW DUET TM CORONARY STENT SYSTEMS
Classification Namestent, coronary
Generic Nameintravascular coronary stent
ApplicantGUIDANT CORP.
PMA NumberP970020
Supplement NumberS004
Date Received05/14/1998
Decision Date11/05/1998
Product Code
MAF[ Registered Establishments with MAF ]
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 the acs multi-link rx duet(tm) and acs multi-link otw duet(tm) coronary stent systems. These devices are indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo and restenotic lesions in native coronary arteries (length < 25mm) with a reference vessel diameter ranging from 3. 0 mm to 4. 0 mm.
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