|
Device | NOVOSTE BETA-CATH SYSTEM |
Generic Name | Intravascular radiation delivery system |
Applicant | BEST VASCULAR, INC 4350 INTERNATIONAL BOULEVARD NORCROSS, GA 30093 |
PMA Number | P000018 |
Supplement Number | S033 |
Date Received | 05/12/2003 |
Decision Date | 06/11/2003 |
Product Code |
MOU |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CONVERTING DEMONSTRATOR DEVICES TO COMMERCIALLY AVAILABLE DEVICES BY ADDING AN ANTIMICROBIAL FLUSH TO THE MANUFACTURING PROCESS. |
Post-Approval Study | Show Report Schedule and Study Progress |