Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | ION 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 | P100023 |
Supplement Number | S094 |
Date Received | 03/31/2014 |
Decision Date | 05/01/2014 |
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 CHANGE TO ADD A NEW ETHYLENE OXIDE STERILIZATION CHAMBER. |
|
|