PMA P960043S109
- Device
- Perclose ProGlide Suture-Mediated Closure System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P960043
- Supplement
- S109
- Product code
- MGB
- Decision date
- 2020-10-01
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Automation of an existing manual inspection process through the introduction of alternate automated test equipment for the subject device.
Current openFDA PMA Record#
- Device
- Perclose ProGlide Suture-Mediated Closure System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P960043
- Supplement
- S109
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2020-10-01
- Decision code
- OK30
- Date received
- 2020-09-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Automation of an existing manual inspection process through the introduction of alternate automated test equipment for the subject device.