|
Device | TAXUS EXPRESS 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 | P030025 |
Supplement Number | S039 |
Date Received | 09/21/2006 |
Decision Date | 02/12/2007 |
Withdrawal Date
|
12/06/2018 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL TO ADD AN AUTOMATED STENT INSPECTION STEP FOR THE STENT COMPONENT OF THE DEVICE. |