|
Device | EXPRESS AND EXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS |
Generic Name | STENT, CORONARY |
Applicant | BOSTON SCIENTIFIC SCIMED, INC. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P020009 |
Supplement Number | S012 |
Date Received | 10/06/2003 |
Decision Date | 10/24/2003 |
Withdrawal Date
|
12/06/2018 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL TO ADD A QUALITY CONTROL TEST TO EVALUATE THE ELONGATION PROPERTY OF THE EXTRUDED DISTAL OUTER SHAFT COMPONENT FOR THE EXPRESS2 STENT DELIVERY CATHETER. |