Beta-Cath System
FDA premarket approval P000018/S050 · decided 2019-09-19
Approval details
- PMA number
- P000018
- Supplement
- S050
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Beta-Cath System
- Generic name
- Intravascular radiation delivery system
- Applicant
- Best Vascular, Inc.
- Date received
- 2019-07-30
- Decision date
- 2019-09-19
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Norcross, GA
- Statement
- Approval for the design and manufacturing changes to your Indicator of Source Train.
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