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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameACS MULTI-LINK TM CORONARY STENT SYSTEM
Classification Namestent, coronary
ApplicantABBOTT VASCULAR INC.
PMA NumberP970020
Date Received06/12/1997
Decision Date10/02/1997
Product Code
MAF[ Registered Establishments with MAF ]
Docket Number 98M-0971
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the acs multi-link(tm) coronary stent system containing acs multi-link(tm) css, acs rx multi-link(tm) coronary stent system containing acs multi-link(tm) css, acs rx multi-link hp(tm) css, acs otw multi-link hp(tm) css, and acs rx multi-link(tm) css delivery platforms. The device with acs multi-link(tm) css, acs rx multi-link hp(tm) css and acs otw multi-link hp(tm) css delivery platforms is indicated for use in patients with symptomatic ischemic heart disease due to discrete de novo and restenotic native coronary artery lesions (length <20 mm) with a reference vessel diameter ranging from 3. 0 mm to 3. 75 mm and is intended to improve coronary luminal diameter. The device with acs rx multi-link(tm) css delivery platform, however, is indicated for use in patients with symptomatic ischemic heart disease due to discrete de novo and restenotic native coronary artery lesions (length <22mm) with a reference vessel diameter ranging from 3. 0 mm to 3. 5 mm and is intended to improve coronary luminal diameter.
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