|
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 | S086 |
Date Received | 12/17/2012 |
Decision Date | 10/10/2014 |
Withdrawal Date
|
08/28/2020 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. |