PMA P140030S017
- Device
- Astron
- Applicant
- Biotronik AG
- PMA number
- P140030
- Supplement
- S017
- Product code
- NIO
- Decision date
- 2025-03-03
- Classification
- Cardiovascular
- Generic name
- STENT, ILIAC
- Approval order statement
- Approval for dimensional modifications to the Luer lock connectors and manifolds as well as the corresponding injection molding equipment
Current openFDA PMA Record#
- Device
- Astron
- Applicant
- Biotronik AG
- PMA number
- P140030
- Supplement
- S017
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2025-03-03
- Decision code
- APPR
- Date received
- 2024-12-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for dimensional modifications to the Luer lock connectors and manifolds as well as the corresponding injection molding equipment