|
Device | TAXUS EXPRESS2 PACLITAXEL 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 | S021 |
Date Received | 08/02/2005 |
Decision Date | 09/24/2008 |
Withdrawal Date
|
12/06/2018 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR STENT DIAMETERS WHICH EXPAND THE PRODUCT MATRIX TO INCLUDE 2.25 MM AND 4.0MM TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEMS. THE DEVICE, ASMODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TAXUS EXPRESS2 PACLITAXEL-ELUTINGCORONARY STENT SYSTEM (MONORAIL, MR AND OVER-THE-WIRE, OTW) AND IS INDICATED FOR THEFOLLOWING: THE TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM IS INDICATED FOR IMPROVINGLUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >2.25 TO<4.0MM IN DIAMETER IN LESIONS < 28MM IN LENGTH. |
Post-Approval Study | Show Report Schedule and Study Progress |