PMA P110028

Device
Absolute Pro Vascular
Applicant
Abbott Vascular, Inc.
PMA number
P110028
Supplement
S023
Product code
NIO
Decision date
2025-10-22
Generic name
STENT, ILIAC
Approval order statement
approval for a change to the sponge used during the catheter lubricious coating application process

Current openFDA PMA Record#

Device
Absolute Pro Vascular
Applicant
Abbott Vascular, Inc.
PMA number
P110028
Supplement
S025
Product code
NIO
Generic name
STENT, ILIAC
Decision date
2025-10-22
Decision code
OK30
Date received
2025-09-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
approval for a change to the sponge used during the catheter lubricious coating application process