|
Device | CYPHER SIROLIMUS-ELUTING CORONARY STENT |
Generic Name | Coronary drug-eluting stent |
Applicant | CORDIS CORP. 6500 Paseo Padre Parkway Fremont, CA 94555 |
PMA Number | P020026 |
Supplement Number | S085 |
Date Received | 05/06/2011 |
Decision Date | 01/26/2012 |
Withdrawal Date
|
08/28/2020 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL TO INTEGRATE THE XTEND MANUFACTURING PROCESS INTO THE CYPHER STENT MOUNTED ON THE SONIX RX DELIVERY SYSTEM. |