|
Device | SCIMED TIPS WALLSTENT SYSTEM |
Generic Name | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P930031 |
Supplement Number | S010 |
Date Received | 07/12/2001 |
Decision Date | 08/13/2001 |
Product Code |
MIR |
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 A CHANGE TO A WARNING STATEMENT IN THE INSTRUCTIONS FOR USE MANUAL. |