|
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 | S005 |
Date Received | 12/24/2002 |
Decision Date | 01/24/2003 |
Withdrawal Date
|
12/06/2018 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE (IFU) TO MORE CLEARLY INSTRUCT THE USER REGARDING THE METHODS FOR REMOVAL OF AN UNEXPANDED STENT. |