PMA P180025
- Device
- MANTA™ Vascular Closure Device
- Applicant
- Teleflex Medical, LLC
- PMA number
- P180025
- Supplement
- S009
- Product code
- MGB
- Decision date
- 2026-04-23
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- a change to the microbiology test laboratory location for the MANTA product family
Current openFDA PMA Record#
- Device
- MANTA™ Vascular Closure Device
- Applicant
- Teleflex Medical, LLC
- PMA number
- P180025
- Supplement
- S016
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2026-04-23
- Decision code
- OK30
- Date received
- 2026-03-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the microbiology test laboratory location for the MANTA product family