PMA P000018S050
- Device
- Beta-Cath System
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S050
- Product code
- MOU
- Decision date
- 2019-09-19
- Classification
- Intravascular Radiation Delivery System
- Generic name
- Intravascular radiation delivery system
- Approval order statement
- Approval for the design and manufacturing changes to your Indicator of Source Train.
Current openFDA PMA Record#
- Device
- Beta-Cath System
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S050
- Product code
- MOU
- Generic name
- Intravascular radiation delivery system
- Decision date
- 2019-09-19
- Decision code
- APPR
- Date received
- 2019-07-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the design and manufacturing changes to your Indicator of Source Train.