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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.
 
DeviceACS AND ACS RX MULTI-LINK CORONARY STENT SYSTEMS
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
ABBOTT VASCULAR INC.
26531 ynez road
temecula, CA 92591
PMA NumberP970020
Supplement NumberS005
Date Received08/17/1998
Decision Date02/18/1999
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 to add the indication for abrupt or threatened abrupt closure to the product labeling for the ACS Multi-Link(TM) (OTW, RX HP(TM), and OTW HP(TM)), ACS Multi-Link RX, ACS Multi-Link (RX and OTW) Duet(TM) Coronary Stent Systems (CSS); and approval for additional stent sizes for the ACS Multi-Link RX (stents with 2.5 mm diameter or 35 mm length) and ACS Multi-Link (RX and OTW) Duet(TM) (stents with 2.5 mm diameter or 38 mm length)CSS. These devices are indicated for use as follows: The ACS Multi-Link(TM) OTW, RX HP(TM), and OTW HP(TM) CSS is indicated for use in patients with symptomatic ischemic heart disease: due to discrete de novo native coronary artery lesions (length < 20 mm) with a reference vessel diameter ranging from 3.0 mm to 3.75 mm; due to discrete restenotic native coronary artery lesions (length < 20mm) with a reference vessel deameter ranging from 3.0 mm to 3.75mm; presenting with abrupt or threatened abrupt closure of native coronary arteries (lesion length < 20mm) with a reference vessel diameter ranging from 3.0mm to 3.75mm); and is intended to improve coronary luminal diameter. Long term outcome (beyond six months) for this permanent implant is unknown at present. The ACS Multi-Link(TM) RX CSS is indicated for use in patients with symptomatic ischemic heart disease: due to discrete de novo native coronary artery lesions (length < 22mm) with a reference vessel diameter raning from 3.0mm to 3.5mm; due to discrete restenotic native coronary artery lesions (length <22mm) with a reference vessel diameter raning from 3.0mm to 3.5mm; presenting with abrupt or threatened abrupt closure of native coronary arteries (lesion length <32mm) with a reference vessel diameter raning from 2.5mm to 3.5mm; and is intended to improve coronary luminal diameter. Long term outcome (beyond six months) for this permanent implant is unknown at present. Note: The 2.5mm diamter and 35mm length stents are indicated solely for use in patients with abrupt or threatened
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