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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 Nameintravascular coronary stent
PMA NumberP000011
Supplement NumberS002
Date Received01/18/2001
Decision Date07/03/2001
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the 11 mm and 15 mm biodivysio(tm) as otw. The device, as modified, will be marketed under the trade name biodivysio(tm) as otw and is indicated for: "use in subjects with symptomatic ischemic heart disease due to de novo native coronary artery lesions (length <= 25 mm) with a reference vessel diameter ranging from >= 3. 0 mm to <= 4. 0 mm and intended to improve coronary lumen diameter. Long term outcome (beyond 6 months) for this permanent implant is unknown at present. ".