PMA P000018S048

Device: NOVOSTE BETA-CATH SYSTEM
Applicant: Best Vascular, Inc.
PMA number: P000018
Supplement: S048
Product code: MOU
Decision date: 2017-07-13
Classification: Intravascular Radiation Delivery System
Generic name: Intravascular radiation delivery system
Approval order statement: Approval for a reduction in the existing minimum dose rate of the Jacketed Radiation Source Trains (JRST) of the Beta-Cath 3.5Fr System from 78.2mGy/s to 64.4mGy/s.

Current openFDA PMA Record#

Device: NOVOSTE BETA-CATH SYSTEM
Applicant: Best Vascular, Inc.
PMA number: P000018
Supplement: S048
Product code: MOU
Generic name: Intravascular radiation delivery system
Decision date: 2017-07-13
Decision code: APPR
Date received: 2016-08-19
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a reduction in the existing minimum dose rate of the Jacketed Radiation Source Trains (JRST) of the Beta-Cath 3.5Fr System from 78.2mGy/s to 64.4mGy/s.