PMA P180025S008
- Device
- MANTA Vascular Closure Device
- Applicant
- Teleflex Medical, LLC
- PMA number
- P180025
- Supplement
- S008
- Product code
- MGB
- Decision date
- 2020-09-18
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Implementation of Keyence Systems to aid the toggle tuck inspection, to automate the suture spooling inspection, and to automate the toggle angle inspection.
Current openFDA PMA Record#
- Device
- MANTA Vascular Closure Device
- Applicant
- Teleflex Medical, LLC
- PMA number
- P180025
- Supplement
- S008
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2020-09-18
- Decision code
- OK30
- Date received
- 2020-08-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of Keyence Systems to aid the toggle tuck inspection, to automate the suture spooling inspection, and to automate the toggle angle inspection.