|
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 | S111 |
Date Received | 11/21/2014 |
Decision Date | 12/18/2014 |
Withdrawal Date
|
12/06/2018 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement ADD ADDITIONAL LINES FOR THE MANUFACTURE OF THE STENT DELIVERY CATHETER OUTER COMPONENT AT THE GALWAY IRELAND MANUFACTURING FACILITY. |