PMA P110028S021

Device
Absolute Pro Vascular Self-Expanding Stent System
Applicant
Abbott Vascular, Inc.
PMA number
P110028
Supplement
S021
Product code
NIO
Decision date
2020-08-28
Generic name
STENT, ILIAC
Approval order statement
Adding automated tab welding equipment and modifying tab weld geometry.

Current openFDA PMA Record#

Device
Absolute Pro Vascular Self-Expanding Stent System
Applicant
Abbott Vascular, Inc.
PMA number
P110028
Supplement
S021
Product code
NIO
Generic name
STENT, ILIAC
Decision date
2020-08-28
Decision code
OK30
Date received
2020-08-05
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Adding automated tab welding equipment and modifying tab weld geometry.