PMA P180025S002
- Device
- MANTA Vascular Closure Device
- Applicant
- Teleflex Medical, LLC
- PMA number
- P180025
- Supplement
- S002
- Product code
- MGB
- Decision date
- 2019-05-15
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Adjustment to the collagen plug weight acceptance criterion for the 18F MANTA VCD.
Current openFDA PMA Record#
- Device
- MANTA Vascular Closure Device
- Applicant
- Teleflex Medical, LLC
- PMA number
- P180025
- Supplement
- S002
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2019-05-15
- Decision code
- OK30
- Date received
- 2019-04-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adjustment to the collagen plug weight acceptance criterion for the 18F MANTA VCD.