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 ON RAPTORRAIL STENT DELIVERY SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. MIAMI LAKES, FL 33014-5700 |
PMA Number | P900043 |
Supplement Number | S027 |
Date Received | 03/21/2001 |
Decision Date | 09/21/2001 |
Withdrawal Date
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09/02/2008 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ELECTIVE INDICATION AS SPECIFIED: FOR 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 TO 5.0 MM. |
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