|
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 | S046 |
Date Received | 11/09/2007 |
Decision Date | 02/08/2008 |
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 THE INTRODUCTION OF A MAXIMUM SPECIFIED TIME FOR PROTECTING AND STORING DEVICES DURING AN ENVIRONMENTAL EXCURSION. |