|
Device | CYPHER SIROLIMUS-ELUTING CORONARY STENTS |
Generic Name | Coronary drug-eluting stent |
Applicant | CORDIS CORP. 6500 Paseo Padre Parkway Fremont, CA 94555 |
PMA Number | P020026 |
Supplement Number | S050 |
Date Received | 03/05/2008 |
Decision Date | 03/23/2009 |
Withdrawal Date
|
08/28/2020 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A CHANGE OF THE TRANSFER OF STENT TRAYS DURING THE SPRAY COATING UNIT OPERATION FROM THE CURRENT METHODOLOGY TO A CONTINUOUS MANNER FROM THE COATING STEP TO ANOTHER. |