PMA P000018S051

Device: Novoste™ Beta-Cath™ System
Applicant: Best Vascular, Inc.
PMA number: P000018
Supplement: S051
Product code: MOU
Decision date: 2024-09-26
Classification: Cardiovascular
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 64.4 mGy/s to 58.5 mGy/s.

Current openFDA PMA Record#

Device: Novoste™ Beta-Cath™ System
Applicant: Best Vascular, Inc.
PMA number: P000018
Supplement: S051
Product code: MOU
Generic name: Intravascular radiation delivery system
Decision date: 2024-09-26
Decision code: APPR
Date received: 2023-05-05
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 64.4 mGy/s to 58.5 mGy/s.