|
Device | TAXUS EXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS |
Generic Name | Coronary drug-eluting stent |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P030025 |
Supplement Number | S002 |
Date Received | 04/05/2004 |
Decision Date | 05/05/2004 |
Withdrawal Date
|
12/06/2018 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL TO IMPLEMENT THE FOLLOWING: 1) THE ADDITION OF AN ADDITIONAL IN-PROCESS INSPECTION, 2) MODIFICATION OF A CURRENT IN-PROCESS INSPECTION, AND 3) MODIFICATION OF A MANUFACTURING PROCESS TO ADDRESS COMPLAINTS RELATED TO FAILURE OF THE DELIVERY SYSTEM BALLOON TO PROPERLY DEFLATE FOLLOWING STENT DEPLOYMENT. |