|
Device | NOVOSTE BETA-CATH 3.5F SYSTEM |
Generic Name | Intravascular radiation delivery system |
Applicant | BEST VASCULAR, INC 4350 INTERNATIONAL BOULEVARD NORCROSS, GA 30093 |
PMA Number | P000018 |
Supplement Number | S026 |
Date Received | 10/18/2002 |
Decision Date | 11/13/2002 |
Product Code |
MOU |
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 MODIFICATIONS TO THE USER'S MANUAL, USER'S GUIDE AND CUSTOMER TRAINING TO INCLUDE ADDITIONAL INFORMATION ON SCENARIOS WHERE THE BETA-RAIL 3.5F DELIVERY CATHETER TIP MAY BE SUBJECTED TO EXCESSIVE FORCE AND THE TECHNIQUES FOR AVOIDING AND/OR RESOLVING THESE SCENARIOS. |
Post-Approval Study | Show Report Schedule and Study Progress |