|
Device | ION PACLITAXEL-ELUTING CORONARY STENT SYTEM |
Generic Name | Coronary drug-eluting stent |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P100023 |
Supplement Number | S081 |
Date Received | 11/25/2013 |
Decision Date | 12/20/2013 |
Withdrawal Date
|
12/06/2018 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00484315
|
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement CHANGES TO THE IN-PROCESS ENDOTOXIN TESTING DURING COMPONENT MANUFACTURING. |
Post-Approval Study | Show Report Schedule and Study Progress |