|
Device | TAXUS EXPRESS2 PACLITAXEL-ELUTING 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 | S042 |
Date Received | 12/07/2006 |
Decision Date | 05/10/2007 |
Withdrawal Date
|
12/06/2018 |
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 TO IMPLEMENT AN ALTERNATE LOCATION FOR PREPARATION OF A HYDROPHILIC COATING SOLUTION COMPONENT KNOWN AS PRE-BIOSLIDE AND APPROVAL FOR AN ALTERNAT SUPPLIER OF THE POLYMER INITIATOR AIBN. |