|
Device | TAXUS EXPRESS2 CORONARY STENT SYSTEM/TAXUS EXPRESS2 ATOM 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 | S085 |
Date Received | 03/08/2010 |
Decision Date | 05/11/2010 |
Withdrawal Date
|
12/06/2018 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MATERIAL AND SPECIFICATION CHANGES TO THE STRAIN RELIEF. |
Post-Approval Study | Show Report Schedule and Study Progress |