PMA P050007
- Device
- StarClose SE™ Vascular Closure System
- Applicant
- Abbott Vascular Devices
- PMA number
- P050007
- Supplement
- S043
- Product code
- MGB
- Decision date
- 2026-04-17
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- implementation of the sustainable ethylene oxide (SEO) cycle in Chamber 1 and Chamber 2 at Sterigenics UK
Current openFDA PMA Record#
- Device
- StarClose SE™ Vascular Closure System
- Applicant
- Abbott Vascular Devices
- PMA number
- P050007
- Supplement
- S049
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2026-04-17
- Decision code
- OK30
- Date received
- 2026-03-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of the sustainable ethylene oxide (SEO) cycle in Chamber 1 and Chamber 2 at Sterigenics UK