|
Device | NOVOSTE(TM) BETA-CATH(TM) SYSTEM |
Generic Name | Intravascular radiation delivery system |
Applicant | BEST VASCULAR, INC 4350 INTERNATIONAL BOULEVARD NORCROSS, GA 30093 |
PMA Number | P000018 |
Supplement Number | S019 |
Date Received | 10/02/2001 |
Decision Date | 05/02/2002 |
Product Code |
MOU |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE NOVOSTE BETA-CATH XL DELIVERY CATHETER (TOTAL LENGTH 267 CM.) TO BE USED WITH THE 30 AND 40 MM NOVOSTE BETA-CATH SYSTEMS. |
Post-Approval Study | Show Report Schedule and Study Progress |