|
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 | S011 |
Date Received | 02/21/2001 |
Decision Date | 08/22/2001 |
Product Code |
MOU |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE DESIGN OF THE PROXIMAL MARKER OF THE SOURCE TRAIN. |