PMA P050007S043
- Device
- StarClose SE Vascular Closure System
- Applicant
- Abbott Vascular Devices
- PMA number
- P050007
- Supplement
- S043
- Product code
- MGB
- Decision date
- 2023-01-31
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Approval for a change in suppliers adhesive formulation and manufacturing.
Current openFDA PMA Record#
- Device
- StarClose SE Vascular Closure System
- Applicant
- Abbott Vascular Devices
- PMA number
- P050007
- Supplement
- S043
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2023-01-31
- Decision code
- APPR
- Date received
- 2022-11-21
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change in suppliers adhesive formulation and manufacturing.