|
Device | TAXUS LIBERTE OVER-THE-WIRE 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 | P060008 |
Supplement Number | S005 |
Date Received | 11/07/2008 |
Decision Date | 11/26/2008 |
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 |
Approval Order Statement CHANGE IN THE METHOD USED TO CREATE THE PROXIMAL MARKS ON THE SHAFT OF THE OVER-THE-WIRE CATHETER. |