|
Device | BX VELOCITY STENT W/HEPACOAT ON RAPTOR/ON SONIC OTW/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 | S041 |
Date Received | 07/24/2002 |
Decision Date | 08/22/2002 |
Withdrawal Date
|
09/02/2008 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE "USED BY" DATING ON THE DEVICES. |