|
Device | TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL, MR AND OVER-THE-WIRE, OTW) |
Generic Name | Coronary drug-eluting stent |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P030025 |
Supplement Number | S010 |
Date Received | 10/25/2004 |
Decision Date | 03/09/2005 |
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 MODIFICATIONS TO LABELING CONTAINED IN THE WARNINGS/ PRECAUTIONS SECTIONS OF THE DIRECTIONS FOR USE (DFU) AND PATIENT GUIDES BASED UPON UPDATED SAFETY INFORMATION RELATED TO MAGNETIC RESONANCE IMAGING (MRI) PERFORMED AT 3 TESLA. |