| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | BX VELOCITY STENT WITH RAPTOR OVER-THE-WIRE (OTW) OR RAPTORRAIL (RX) STENT DELIVERY SYSTEMS (SDS) - SAPHENOUS VEIN GRAFN |
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| Generic Name | STENT, CORONARY |
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| Applicant | CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES, FL 33014-5700 |
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| PMA Number | P900043 |
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| Supplement Number | S042 |
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| Date Received | 10/21/2002 |
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| Decision Date | 03/04/2004 |
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Withdrawal Date
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09/02/2008 |
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| Product Code |
MAF |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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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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