- Device
- Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle Suture-Mediated Closure and Repair System, Prostar X
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P960043
- Supplement
- S120
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2023-01-31
- Decision code
- APPR
- Date received
- 2022-11-21
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change in supplier's adhesive formulation and manufacturing.