|
Device | TAXUS EXPRESS CORONARY STENT SYSTEM |
Generic Name | Coronary drug-eluting stent |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P030025 |
Supplement Number | S005 |
Date Received | 07/01/2004 |
Decision Date | 03/31/2005 |
Withdrawal Date
|
12/06/2018 |
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 TO USE STERIS ISOMEDIX (FORMERLY COSMED OF RHODE ISLAND) AS AN ALTERNATE STERILIZATION SITE FOR DEVICES MANUFACTURED AT GALWAY, IRELAND. |