PMA P040012S060

Device
Acculink Carotid Stent System
Applicant
Abbott Vascular
PMA number
P040012
Supplement
S060
Product code
NIM
Decision date
2020-10-06
Generic name
Stent, carotid
Approval order statement
New suppliers of injection molded components.

Current openFDA PMA Record#

Device
Acculink Carotid Stent System
Applicant
Abbott Vascular
PMA number
P040012
Supplement
S060
Product code
NIM
Generic name
Stent, carotid
Decision date
2020-10-06
Decision code
OK30
Date received
2020-09-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New suppliers of injection molded components.