PMA P180025S014

Device: MANTA™ Vascular Closure Device; MANTA Vascular Closure Device, 18F; MANTA Vascular Closure Device, 14F; MANTA SF Depth L
Applicant: Teleflex Medical, LLC
PMA number: P180025
Supplement: S014
Product code: MGB
Decision date: 2025-08-05
Classification: Cardiovascular
Generic name: Device, hemostasis, vascular
Approval order statement: a change to conduct the final release testing of the Manta VCD product family in a new location within the same facility

Current openFDA PMA Record#

Device: MANTA™ Vascular Closure Device; MANTA Vascular Closure Device, 18F; MANTA Vascular Closure Device, 14F; MANTA SF Depth L
Applicant: Teleflex Medical, LLC
PMA number: P180025
Supplement: S014
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2025-08-05
Decision code: OK30
Date received: 2025-07-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change to conduct the final release testing of the Manta VCD product family in a new location within the same facility