PMA P030047S042

Device
Cordis PRECISE Nitinol Stent System
Applicant
Cordis US Corporation
PMA number
P030047
Supplement
S042
Product code
NIM
Decision date
2021-04-01
Generic name
Stent, carotid
Approval order statement
Implementing recertification procedures for returned stents.

Current openFDA PMA Record#

Device
Cordis PRECISE Nitinol Stent System
Applicant
Cordis US Corporation
PMA number
P030047
Supplement
S042
Product code
NIM
Generic name
Stent, carotid
Decision date
2021-04-01
Decision code
OK30
Date received
2021-03-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementing recertification procedures for returned stents.