- Device
- Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle Suture-Mediated Closure and Repair System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P960043
- Supplement
- S117
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2022-08-23
- Decision code
- OK30
- Date received
- 2022-07-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualification of manufacturing room (Suite 5) at a higher occupancy of equipment and personnel than the initial qualification.