PMA P000018S035

Device: NOVOSTE BETA-CATH SYSTEM
Applicant: Best Vascular, Inc.
PMA number: P000018
Supplement: S035
Product code: MOU
Decision date: 2004-02-17
Classification: Intravascular Radiation Delivery System
Generic name: Intravascular radiation delivery system
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE ALPHA-SERIES TRANSFER DEVICES (ALPHA IV, REV. 2, ALPHA V, AND ALPHA VI), AND MODIFICATIONS TO THE LABELING FOR THE BETA-CATH 5F AND BETA-CATH 3.5F SYSTEMS.

Current openFDA PMA Record#

Device: NOVOSTE BETA-CATH SYSTEM
Applicant: Best Vascular, Inc.
PMA number: P000018
Supplement: S035
Product code: MOU
Generic name: Intravascular radiation delivery system
Decision date: 2004-02-17
Decision code: APPR
Date received: 2003-08-21
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE ALPHA-SERIES TRANSFER DEVICES (ALPHA IV, REV. 2, ALPHA V, AND ALPHA VI), AND MODIFICATIONS TO THE LABELING FOR THE BETA-CATH 5F AND BETA-CATH 3.5F SYSTEMS.