PMA P000018S046
- Device
- NOVOSTE BETA-CATH SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S046
- Product code
- MOU
- Decision date
- 2016-10-06
- Classification
- Intravascular Radiation Delivery System
- Generic name
- Intravascular radiation delivery system
- Approval order statement
- Approval to extend the service life of the PCBA and PIB components located in the Transfer Device to 26 months.
Current openFDA PMA Record#
- Device
- NOVOSTE BETA-CATH SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S046
- Product code
- MOU
- Generic name
- Intravascular radiation delivery system
- Decision date
- 2016-10-06
- Decision code
- APPR
- Date received
- 2014-11-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to extend the service life of the PCBA and PIB components located in the Transfer Device to 26 months.