PMA P180025S009
- Device
- MANTA Vascular Closure Device
- Applicant
- Teleflex Medical, LLC
- PMA number
- P180025
- Supplement
- S009
- Product code
- MGB
- Decision date
- 2021-04-19
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Approval for the addition of an additional depth locator, size 14F, to be packaged separately from the MANTA Vascular Closure Device.
Current openFDA PMA Record#
- Device
- MANTA Vascular Closure Device
- Applicant
- Teleflex Medical, LLC
- PMA number
- P180025
- Supplement
- S009
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2021-04-19
- Decision code
- APPR
- Date received
- 2021-02-10
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of an additional depth locator, size 14F, to be packaged separately from the MANTA Vascular Closure Device.