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. |
|
Device | BX VELOCITY(TM) WITH HEPACOAT(TM) ON RAPTOR (TM) STENT SYSTEM FOR CORONARY ARTERIES |
Generic Name | STENT, CORONARY |
Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. MIAMI LAKES, FL 33014-5700 |
PMA Number | P900043 |
Supplement Number | S024 |
Date Received | 02/08/2000 |
Decision Date | 07/21/2000 |
Withdrawal Date
|
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 ADDITION OF A HEPARIN COATING TO THE BX VELOCITY(TM) CORONARY STENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BX VELOCITY(TM) WITH HEPACOAT(TM) ON RAPTOR(TM) STENT SYSTEM AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE TREATMENT OF 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 TO 4.00 MM. |
|
|