|
Device | NOVOSTE 60 MM BETA-CATH 5 FR SYSTEM |
Generic Name | Intravascular radiation delivery system |
Applicant | BEST VASCULAR, INC 4350 INTERNATIONAL BOULEVARD NORCROSS, GA 30093 |
PMA Number | P000018 |
Supplement Number | S018 |
Date Received | 08/31/2001 |
Decision Date | 03/25/2002 |
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 NOVOSTE BETA-CATH 60 MM 5 FR SYSTEM. THE NOVOSTE BETA-CATH 60 MM 5 FR SYSTEM IS INTENDED TO DELIVER BETA RADIATION TO THE SITE OF SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR THE TREATMENT OF IN-STENT RESTENOSIS IN NATIVE CORONARY ARTERIES WITH DISCRETE LESIONS WITH INJURY AREAS UP TO 40 MM IN A REFERENCE VESSLE DIAMETER RANGING FROM 2.7 MM TO 4.0 MM. |