|
Device | BETA-CATH 3.5F SYSTEM - 60 MM |
Generic Name | Intravascular radiation delivery system |
Applicant | BEST VASCULAR, INC 4350 INTERNATIONAL BOULEVARD NORCROSS, GA 30093 |
PMA Number | P000018 |
Supplement Number | S028 |
Date Received | 01/06/2003 |
Decision Date | 06/25/2003 |
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 60 MM BETA-CATH 3.5F SYSTEM. THE DEVICE, AS MODIFIED, IS INDICATED 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 (TREATABLE WITH A 20 MM BALLOON FOR THE 30 MM AND 40 MM SYSTEMS AND INJURY AREAS UP TO 40 MM FOR THE 60 MM SYSTEM) IN A REFERENCE VESSEL DIAMETER RANGING FROM 2.7 MM TO 4.0 MM. |