|
Device | TAXUS LIBERTE OTW 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 | P060008 |
Supplement Number | S075 |
Date Received | 08/31/2011 |
Decision Date | 09/27/2011 |
Withdrawal Date
|
12/06/2018 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement CHANGES TO PROCESS METHODS AND SOFTWARE SUPPORTING THE PLASMA TREATER AND THE HYDROPHILIC COATING (HPC) EQUIPMENT. |