PMA P000018S042

Device: BETA-CATH SYSTEM
Applicant: Best Vascular, Inc.
PMA number: P000018
Supplement: S042
Product code: MOU
Decision date: 2006-06-16
Classification: Intravascular Radiation Delivery System
Generic name: Intravascular radiation delivery system
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE BETA-CATH SYSTEM LABELING, SPECIFICALLY THE INCORPORATION OF THE START/START 40/20 5-YEAR POST-APPROVAL STUDY RESULTS IN THE BETA-CATH INSTRUCTIONS FOR USE.

Current openFDA PMA Record#

Device: BETA-CATH SYSTEM
Applicant: Best Vascular, Inc.
PMA number: P000018
Supplement: S042
Product code: MOU
Generic name: Intravascular radiation delivery system
Decision date: 2006-06-16
Decision code: APPR
Date received: 2006-03-09
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE BETA-CATH SYSTEM LABELING, SPECIFICALLY THE INCORPORATION OF THE START/START 40/20 5-YEAR POST-APPROVAL STUDY RESULTS IN THE BETA-CATH INSTRUCTIONS FOR USE.