|
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 | S011 |
Date Received | 10/01/2004 |
Decision Date | 05/29/2005 |
Withdrawal Date
|
08/28/2020 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR AN ANALYTICAL TESTING LABORATORY LOCATED AT PHARMACEUTICAL SOURCING GROUP AMERICAS (PSGA), ALSO KNOWN AS JANSSEN PHARMACEUTICALS, INC., TITUSVILLE, NEW JERSEY. |