- Device
- StarClose SE Vascular Closure System
- Applicant
- Abbott Vascular Devices
- PMA number
- P050007
- Supplement
- S041
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2021-06-15
- Decision code
- OK30
- Date received
- 2021-05-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Increase the maximum pressure for the Clip Applier wire control machine that is used during the wire controller assembly process for StarClose SE® Vascular Closure System