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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.
Classification Namestent, coronary
Generic Namestent, coronary
26531 ynez road
temecula, CA 92591
PMA NumberP970020
Supplement NumberS021
Date Received03/17/2000
Decision Date09/08/2000
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 the acs multi-link rx and otw ultra(tm) coronary stent systems. The devices are indicated for improving coronary lumen diameter in the following: 1) patients with syntomatic ischemic disease due to discrete de novo or restenotic native coronary artery lesions (length <= 25 mm) with a reference vessel diameter of 3. 5 mm to 5. 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 3. 5 mm to 5. 0 mm. Long term outcome for this permanent implant is unknown at present. Note: the 38 mm length stents are solely indicated for use in patients with abrupt or threatened abrupt closure.