PMA P000018S028

Device: BETA-CATH 3.5F SYSTEM - 60 MM
Applicant: Best Vascular, Inc.
PMA number: P000018
Supplement: S028
Product code: MOU
Decision date: 2003-06-25
Classification: Intravascular Radiation Delivery System
Generic name: Intravascular radiation delivery system
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.

Current openFDA PMA Record#

Device: BETA-CATH 3.5F SYSTEM - 60 MM
Applicant: Best Vascular, Inc.
PMA number: P000018
Supplement: S028
Product code: MOU
Generic name: Intravascular radiation delivery system
Decision date: 2003-06-25
Decision code: APPR
Date received: 2003-01-06
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.