PMA P960043S114
- Device
- Perclose ProGlide Suture-Mediated Closure System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P960043
- Supplement
- S114
- Product code
- MGB
- Decision date
- 2021-09-22
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Removal of a redundant adhesive application step during subassembly manufacturing of the ProGlide Suture-Mediated Closure System.
Current openFDA PMA Record#
- Device
- Perclose ProGlide Suture-Mediated Closure System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P960043
- Supplement
- S114
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2021-09-22
- Decision code
- OK30
- Date received
- 2021-08-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of a redundant adhesive application step during subassembly manufacturing of the ProGlide Suture-Mediated Closure System.