|
Device | TAXUS EXPRESS2 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 | S030 |
Date Received | 04/13/2006 |
Decision Date | 05/01/2006 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement MODIFICATION OF THE EQUIPMENT NOZZLE TO THE MOLD USED FOR MAKING THE MANIFOLD. |
Post-Approval Study | Show Report Schedule and Study Progress |