PMA P180025S015

Device
MANTA™ Vascular Closure Device
Applicant
Teleflex Medical, LLC
PMA number
P180025
Supplement
S015
Product code
MGB
Decision date
2026-02-27
Classification
Cardiovascular
Generic name
Device, hemostasis, vascular
Approval order statement
a change in the location for final release testing of the MANTA™ Vascular Closure Device (VCD) product family

Current openFDA PMA Record#

Device
MANTA™ Vascular Closure Device
Applicant
Teleflex Medical, LLC
PMA number
P180025
Supplement
S015
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2026-02-27
Decision code
OK30
Date received
2026-02-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
a change in the location for final release testing of the MANTA™ Vascular Closure Device (VCD) product family