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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 NameBX VELOCITY STENT WITH RAPTOR OVER-THE-WIRE (OTW) OR RAPTORRAIL (RX) STENT DELIVERY SYSTEMS (SDS) - SAPHENOUS VEIN GRAFN
Classification Namestent, coronary
Generic Namecoronary stent and delivery system
ApplicantCORDIS CORP.
PMA NumberP900043
Supplement NumberS042
Date Received10/21/2002
Decision Date03/04/2004
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new saphenous vein graft (svg) indication for the bx velocity stent with raptor over-the-wire (otw) or raptorrail (rx) stent delivery systems (sds). The device is indicated for the treatment of: patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions (<= 30 mm in length) in native coronary arteries with reference diameters ranging from 3. 0 mm to 5. 0 mm; abrupt or threatened vessel closure in patients with failed interventional therapy in lesions (<= 30 mm in length) with reference diameters in the range of 2. 25 mm to 4. 00 mm; and, patients with de novo or restenotic saphenous vein graft lesions (<= 30 mm in length) with reference diameters ranging from 3. 0 mm to 5. 0 mm.
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