|
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 | S011 |
Date Received | 02/02/2009 |
Decision Date | 07/13/2009 |
Withdrawal Date
|
12/06/2018 |
Product Code |
NIQ |
Docket Number | 09M-0369 |
Notice Date | 08/04/2009 |
Advisory Committee |
Cardiovascular |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL TO EXPAND THE PRODUCT MATRIX TO INCLUDE THE 38 MM LENGTH TAXUS LIBERTÉ PACLITAXEL-ELUTING CORONARY STENT SYSTEM. THE DEVICE SIZE WILL BE MARKETED UNDER THE TRADE NAME TAXUS LIBERTÉ LONG PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS), AND IS INDICATED FOR IMPROVING LUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >=2.75 MM TO <=4.00 MM IN DIAMETER IN LESIONS <=34 MM IN LENGTH. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |