PMA P110028S024

Device
Absolute Pro Vascular Self-Expanding Stent System
Applicant
Abbott Vascular, Inc.
PMA number
P110028
Supplement
S024
Product code
NIO
Decision date
2025-07-22
Classification
Cardiovascular
Generic name
STENT, ILIAC
Approval order statement
approval for changes made to the equipment set up parameters

Current openFDA PMA Record#

Device
Absolute Pro Vascular Self-Expanding Stent System
Applicant
Abbott Vascular, Inc.
PMA number
P110028
Supplement
S024
Product code
NIO
Generic name
STENT, ILIAC
Decision date
2025-07-22
Decision code
OK30
Date received
2025-07-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
approval for changes made to the equipment set up parameters