PMA P150006

Device
CELT ACD Vascular Closure Device
Applicant
Vasorum, Ltd.
PMA number
P150006
Supplement
S004
Product code
MGB
Decision date
2025-12-18
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
a new adhesive to be used in the Tyvek packaging lid

Current openFDA PMA Record#

Device
CELT ACD Vascular Closure Device
Applicant
Vasorum, Ltd.
PMA number
P150006
Supplement
S007
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2025-12-18
Decision code
OK30
Date received
2025-12-05
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
a new adhesive to be used in the Tyvek packaging lid