Novoste Beta-Cath System
FDA premarket approval P000018/S051 · decided 2024-09-26
Approval details
- PMA number
- P000018
- Supplement
- S051
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Novoste Beta-Cath System
- Generic name
- Intravascular radiation delivery system
- Applicant
- Best Vascular, Inc.
- Date received
- 2023-05-05
- Decision date
- 2024-09-26
- Days to decision
- 510 days
- Decision code
- APPR
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Norcross, GA
- 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.
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