|
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 | S008 |
Date Received | 02/02/2001 |
Decision Date | 10/26/2001 |
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 STERILE BAG AND FLUID COLLECTION BAG PROVIDED IN THE PROCEDURE ACCESSORY PACK. |
Post-Approval Study | Show Report Schedule and Study Progress |