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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMULTI-LINK ULTRA/ ZETA CORONARY STENT SYSTEMS
Generic NameSTENT, CORONARY
ApplicantABBOTT VASCULAR INC.
26531 YNEZ ROAD
TEMECULA, CA 92591
PMA NumberP970020
Date Received06/12/1997
Decision Date10/02/1997
Withdrawal Date04/15/2025
Product Code MAF 
Docket Number 98M-0971
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
Supplements: S052 S003 S004 S005 S042 S055 S083 S033 S034 S035 S036 S019 
S020 S021 S022 S045 S001 S002 S058 S059 S027 S028 S029 S030 
S031 S032 S056 S044 S047 S061 S062 S063 S064 S065 S066 S067 
S068 S069 S070 S071 S073 S074 S079 S080 S081  S015 S017 
S018 S075 S076 S077 S078 S053 S046 S026 S082 S023 S024 S006 
S007 S008 S009 S011 S012 S014 S043 S049 S050 S051 S057 S037 
S038 S039 S040 S041 S048 S054 S084 S086 S085 
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