- Device
- Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle Suture-Mediated Closure and Repair System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P960043
- Supplement
- S116
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2022-07-14
- Decision code
- OK30
- Date received
- 2022-06-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a replicate manufacturing line within the existing approved facility for the Perclose ProGlide and Perclose ProStyle Suture-Mediated Closure and Repair Systems.