PMA P000018S015

Device: NOVOSTE BETA-CATH 3.5 FR SYSTEM
Applicant: Best Vascular, Inc.
PMA number: P000018
Supplement: S015
Product code: MOU
Decision date: 2002-02-08
Classification: Intravascular Radiation Delivery System
Generic name: Intravascular radiation delivery system
Approval order statement: APPROVAL FOR THE NOVOSTE BETA-CATH 3.5 FR SYSTEM. THE NOVOSTE BETA-CATH 3.5 FR SYSTEM 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) IN A REFERENCE VESSEL DIAMETER RANGING FROM 2.7 MM TO 4.0 MM.

Current openFDA PMA Record#

Device: NOVOSTE BETA-CATH 3.5 FR SYSTEM
Applicant: Best Vascular, Inc.
PMA number: P000018
Supplement: S015
Product code: MOU
Generic name: Intravascular radiation delivery system
Decision date: 2002-02-08
Decision code: APPR
Date received: 2001-07-31
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE NOVOSTE BETA-CATH 3.5 FR SYSTEM. THE NOVOSTE BETA-CATH 3.5 FR SYSTEM 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) IN A REFERENCE VESSEL DIAMETER RANGING FROM 2.7 MM TO 4.0 MM.