|
Device | ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM |
Generic Name | Coronary drug-eluting stent |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P100023 |
Supplement Number | S100 |
Date Received | 05/05/2014 |
Decision Date | 06/04/2014 |
Withdrawal Date
|
12/06/2018 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement REMOVE THE MANUAL INSPECTION OF THE DISTANCE BETWEEN THE BI-COMPONENT ASSEMBLY (BOND) AND PROXIMAL BALLOON BOND. |