PMA P050007S048

Device: StarClose SE™ Vascular Closure System
Applicant: Abbott Vascular Devices
PMA number: P050007
Supplement: S048
Product code: MGB
Decision date: 2026-03-02
Classification: Cardiovascular
Generic name: Device, hemostasis, vascular
Approval order statement: a modification to the sustainable ethylene oxide (SEO) cycle previously approved for Line 1, Line 2, Line 14 and Line 15 at Synergy Health Ireland and implementation of the SEO cycle at Sterigenics Los Angeles

Current openFDA PMA Record#

Device: StarClose SE™ Vascular Closure System
Applicant: Abbott Vascular Devices
PMA number: P050007
Supplement: S048
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2026-03-02
Decision code: OK30
Date received: 2026-02-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a modification to the sustainable ethylene oxide (SEO) cycle previously approved for Line 1, Line 2, Line 14 and Line 15 at Synergy Health Ireland and implementation of the SEO cycle at Sterigenics Los Angeles