|
Device | TAXUS LIBERTE 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 | S047 |
Date Received | 03/19/2010 |
Decision Date | 05/17/2010 |
Withdrawal Date
|
12/06/2018 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR MR COMPATIBILITY LABELING CHANGES TO THE DIRECTIONS FOR USE (DFU) AND PATIENT INFORMATION GUIDE (PG) FOR THE TAXUS LIBERTÉ MONORAIL (MR) AND OVER-THE-WIRE (OTW) STENT DELIVERY SYSTEMS. |