PMA P030047S044

Device
Cordis PRECISE Nitinol Stent System
Applicant
Cordis US Corporation
PMA number
P030047
Supplement
S044
Product code
NIM
Decision date
2022-04-27
Generic name
Stent, carotid
Approval order statement
Automation of a welding process for the delivery system.

Current openFDA PMA Record#

Device
Cordis PRECISE Nitinol Stent System
Applicant
Cordis US Corporation
PMA number
P030047
Supplement
S044
Product code
NIM
Generic name
Stent, carotid
Decision date
2022-04-27
Decision code
OK30
Date received
2022-04-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Automation of a welding process for the delivery system.