PMA P030047S036

Device
Cordis PRECISE PRO Rx Nitinol Stent System
Applicant
Cordis US Corporation
PMA number
P030047
Supplement
S036
Product code
NIM
Decision date
2018-12-20
Classification
Stent, Carotid
Generic name
Stent, carotid
Approval order statement
Relocation of manufacturing lines from one building to another within the same establishment.

Current openFDA PMA Record#

Device
Cordis PRECISE PRO Rx Nitinol Stent System
Applicant
Cordis US Corporation
PMA number
P030047
Supplement
S036
Product code
NIM
Generic name
Stent, carotid
Decision date
2018-12-20
Decision code
OK30
Date received
2018-12-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Relocation of manufacturing lines from one building to another within the same establishment.