- Device
- Prostar™ XL Percutaneous Vascular Surgical System, Perclose ProGlide™ Suture-Mediated Closure System, Perclose™ ProStyle
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P960043
- Supplement
- S119
- Decision date
- 2022-12-16
- Decision code
- OK30
- Date received
- 2022-11-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a sustainable ethylene oxide (SEO) sterilization cycle ("soft" cycle) at the Synergy Health Ireland facility.