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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceACS RX MULTI-LINK HP/ACS OTW MULTI LINK HP CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
ABBOTT VASCULAR INC.
26531 ynez road
temecula, CA 92591
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/material
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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