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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, building g
mailing p.o. 9018
temecula, CA 92590-9018
PMA NumberP000011
Supplement NumberS006
Date Received02/01/2002
Decision Date07/26/2002
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the 7 mm stent length (in all diameters, 2. 0, 2. 25 and 2. 5 mm) and 2. 25 mm diameter biodivysio sv otw product to previously approved stent lengths of 10, 15 and 18 mm (supplement 3). The device, as modified, will be marketed under the trade name biodivysio sv otw and is indicated for: "improving coronary luminal diameter in subjects experiencing abrupt closure or threatened abrupt vessel closure following percutaneous revascularization of de novo or non in-stent restenotic native coronary artery lesions (length of lesion and/or dissection <=25 mm) with reference vessel diameter ranging from >=2. 0 mm to <=2. 75 mm by visual estimate. Long-term outcome (beyond 6 months) for this implant is unknown at present.