- Device
- Perclose ProStyle Suture-Mediated Closure and Repair System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P960043
- Supplement
- S113
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2021-09-07
- Decision code
- OK30
- Date received
- 2021-08-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a manufacturing site, Clonmel Ireland, to mix the PVP K-90 solution that is applied to the Perclose Prostyle Suture Trimmer.