PMA P180025S007
- Device
- MANTA Vascular Closure Device
- Applicant
- Teleflex Medical, LLC
- PMA number
- P180025
- Supplement
- S007
- Product code
- MGB
- Decision date
- 2020-05-26
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Implementation of an automated tray component packaging inspection process.
Current openFDA PMA Record#
- Device
- MANTA Vascular Closure Device
- Applicant
- Teleflex Medical, LLC
- PMA number
- P180025
- Supplement
- S007
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2020-05-26
- Decision code
- OK30
- Date received
- 2020-05-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an automated tray component packaging inspection process.