|
Device | TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER -THE-WIRE) |
Generic Name | Coronary drug-eluting stent |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P030025 |
Supplement Number | S028 |
Date Received | 03/13/2006 |
Decision Date | 09/24/2008 |
Withdrawal Date
|
12/06/2018 |
Product Code |
NIQ |
Docket Number | 08M-0547 |
Notice Date | 10/15/2008 |
Advisory Committee |
Cardiovascular |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM ¿ IN-STENT RESTENOSIS (ISR) INDICATION. THE DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >=2.25 TO <=4.00 MM IN DIAMETER IN LESIONS <=28 MM IN LENGTH, AND WITHIN BARE METAL STENT RESTENOTIC LESIONS >=2.25 TO <=3.75 MM IN DIAMETER AND <=28 MM IN LENGTH. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |