|
Device | CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE WIRE DELIVERY |
Generic Name | Coronary drug-eluting stent |
Applicant | CORDIS CORP. 6500 Paseo Padre Parkway Fremont, CA 94555 |
PMA Number | P020026 |
Supplement Number | S013 |
Date Received | 05/05/2005 |
Decision Date | 06/06/2005 |
Withdrawal Date
|
08/28/2020 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR LABELING CHANGES TO BETTER INFORM PATIENTS AND HEALTH CARE PROVIDERS ABOUT THE RISKS OF EARLY DISCONTINUATION OF ANTIPLATELET THERAPY AND THAT RESPONDS TO A LETTER SENT TO CORDIS BY FDA DATED APRIL 21, 2005. |