PMA P040038S045

Device
XACT Transcarotid Stent System (XACT TSS)
Applicant
Abbott Vascular, Inc.
PMA number
P040038
Supplement
S045
Product code
NIM
Decision date
2024-07-15
Classification
Cardiovascular
Generic name
Stent, carotid
Approval order statement
Approval for a shortened delivery system to be used in transcarotid stenting procedures

Current openFDA PMA Record#

Device
XACT Transcarotid Stent System (XACT TSS)
Applicant
Abbott Vascular, Inc.
PMA number
P040038
Supplement
S045
Product code
NIM
Generic name
Stent, carotid
Decision date
2024-07-15
Decision code
APPR
Date received
2024-04-29
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a shortened delivery system to be used in transcarotid stenting procedures