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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 NameMULTI-LINK RX TETRA(TM) CORONARY STENT SYSTEM/ MULTI-LINK OTW TETRA(TM) CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Nameintravascular coronary stent
ApplicantGUIDANT CORP.
PMA NumberP970020
Supplement NumberS023
Date Received04/12/2000
Decision Date10/03/2000
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 and otw tetra(tm) coronary stent systems. The devices are indicated for improving coronary lumen diameter in the following: 1) patients with symptomatic ischemic disease due to discrete de novo or restenotic native coronary artery lesions (length <= 25 mm) with a reference vessel diameter of 3. 0 mm to 4. 0 mm; and 2) treatment of abrupt or threatened abrupt closure in patients with failed interventional therapy in lesions (<= 35 mm in length) with reference diameters in the range of 2. 5 mm to 4. 0 mm. Long term outcome for this permanent implant is unknown at present. Note: the 2. 5 mm and 2. 75 mm diameter stents and the 33 mm and 38 mm length stents are solely indicated for use in patients with abrupt or threatened abrupt closure.
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