|
Device | TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) |
Generic Name | Coronary drug-eluting stent |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P030025 |
Supplement Number | S006 |
Date Received | 09/20/2004 |
Decision Date | 10/21/2004 |
Withdrawal Date
|
12/06/2018 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR LABELING CHANGES THAT STRENGTHEN THE INSTRUCTION REGARDING APPROPRIATE METHODS TO BE USED WHEN A PHYSICIAN EXPERIENCES WITHDRAWAL RESISTANCE FOLLOWING STENT DEPLOYMENT AND BALLOON DEFLATION. |