PMA P040012S061

Device
Acculink Carotid Stent System
Applicant
Abbott Vascular
PMA number
P040012
Supplement
S061
Product code
NIM
Decision date
2021-06-16
Generic name
Stent, carotid
Approval order statement
Alternate supplier of delivery system injection molded components.

Current openFDA PMA Record#

Device
Acculink Carotid Stent System
Applicant
Abbott Vascular
PMA number
P040012
Supplement
S061
Product code
NIM
Generic name
Stent, carotid
Decision date
2021-06-16
Decision code
OK30
Date received
2021-05-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Alternate supplier of delivery system injection molded components.