Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | EXPRESS, EXPRESS2 CORONARY STENT SYSTEM (MOMORAIL AND OVER-THE-WIRE) |
Generic Name | STENT, CORONARY |
Applicant | BOSTON SCIENTIFIC SCIMED, INC. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P020009 |
Supplement Number | S019 |
Date Received | 01/25/2005 |
Decision Date | 02/15/2005 |
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 |
Approval Order Statement APPROVAL FOR LABELING CHANGES THAT STRENGTHEN THE INSTRUCTIONS REGARDING APPROPRIATE METHODS TO BE USED WHEN A PHYSICIAN EXPERIENCES WITHDRAWAL RESISTANCE FOLLOWING STENT DEPLOYMENT AND BALLOON DEFLATION. |
|
|