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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 ZETA CORONARY STENT SYSTEM/ MULTI LINK OTW ZETA CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecoronary stent system
ApplicantGUIDANT CORP.
PMA NumberP970020
Supplement NumberS042
Date Received03/19/2002
Decision Date09/13/2002
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 multi-link rx and otw zeta coronary stent systems. The devices are indicated for improving coronary lumen diameter in the following: 1) patients with symptomatic ischemic heart disease due to discrete de novo or restenotic native coronary artery lesions (length <= 25 mm) with reference vessel diameters ranging from 3. 0 mm to 4. 0 mm. 2) patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts (length <= 35 mm) with reference vessel diameters ranging from 3. 0 mm to 4. 0 mm. 3) restoring coronary flow in patients experiencing acute myocardial infarction, as confirmed by st segment elevation or angiographic findings, who present within 12 hours of symptom onset with native coronary artery lesions of length <= mm with a reference vessel diameter of 2. 5 mm to 4. 0 mm. 4) treatment of abrupt or threatened abrupt closure in patients with failed interventional therapy in lesions (<= 35 mm in length) with reference vessel diameters ranging from 2. 5 mm to 4. 0 mm. Long-term outcome for this permanent implant is unknown at present.
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