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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 PENTA CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecoronary stent system
ApplicantABBOTT VASCULAR-CARDIAC THERAPIES
PMA NumberP970020
Supplement NumberS036
Date Received08/07/2001
Decision Date01/14/2002
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of an indication to use the 3. 0 mm to 4. 0 mm penta(tm) otw and tx for the treatment of svg lesions. The multi-link rx penta and multi-link otw penta coronary stent system will include the following indication: 1) patients with symptomatic ischemic heart disease due to discrete de novo or restenotic native coronary artery lesions (length <=25 mm) with referenc evessel 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; and 3) 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 stents are solely indicated for use in patients with abrupt or threatened abrupt closure. The 33 mm and 38 mm length stents are indicated solely for use in patients with abrupt or threatened abrupt closure and patientw with lesions in saphenous bein bypass grafts.
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