|
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 | S029 |
Date Received | 01/21/2003 |
Decision Date | 07/18/2003 |
Product Code |
MOU |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE BETA-RAIL 3.5F XL DELIVERY CATHETER AND ENHANCED BETA-RAIL 3.5F DELIVERY CATHETER. |
Post-Approval Study | Show Report Schedule and Study Progress |