|
Device | ION 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 | P100023 |
Supplement Number | S015 |
Date Received | 07/15/2011 |
Decision Date | 02/22/2012 |
Withdrawal Date
|
12/06/2018 |
Product Code |
NIQ |
Docket Number | 12M-0208 |
Notice Date | 03/07/2012 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00371475
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL TO EXPAND THE LABELED INDICATIONS FOR THE ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE). THE ION STENT SYSTEM IS INDICATED FOR IMPROVING LUMINAL DIAMETER: 1) FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES 2.25 MM TO 4.00 MM IN DIAMETER IN LESIONS <= 34 MM IN LENGTH; OR 2) IN PATIENTS UNDERGOING PRIMARY ANGIOPLASTY TO TREAT ACUTE ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION, TRUE POSTERIOR MYOCARDIAL INFARCTION, OR PRESUMED NEW LEFT BUNDLE BRANCH BLOCK WITH SYMPTOMS OF ACUTE MYOCARDIAL INFARCTION LASTING > 20 MINUTES AND > 12 HOURS IN DURATION. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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