|
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 | S017 |
Date Received | 03/25/2005 |
Decision Date | 07/08/2005 |
Withdrawal Date
|
12/06/2018 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL TO CHANGE THE IN-PROCESS COATING WEIGHT ACCEPTANCE CRITERIA. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM AND IS INDICATED FOR IMPROVING LUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO LESIONS <28 MM IN LENGTH IN NATIVE CORONARY ARTERIES >=2.5 TO <=3.75 MM IN DIAMETER. |