- Device
- Perclose ProGlide™ Suture-Mediated Closure System; Perclose™ ProStyle™ Suture-Mediated Closure and Repair System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P960043
- Supplement
- S131
- 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