- Device
- Perclose ProGlide Suture-Mediated Closure System and Perclose ProStyle Suture-Mediated Closure and Repair System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P960043
- Supplement
- S128
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2026-08-27
- Decision code
- APPR
- Date received
- 2025-12-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for a change to the final packaging for the Perclose ProGlide Suture-Mediated Closure System and PerClose ProStyle Suture Mediated Closure and repair system