PMA P030047S031

Device
CORDIS PRECISE NITINOL STENT SYSTEMS
Applicant
Cordis US Corporation
PMA number
P030047
Supplement
S031
Product code
NIM
Decision date
2015-05-28
Classification
Stent, Carotid
Generic name
Stent, carotid
Approval order statement
USE AN ALTERNATE STABILIZING ADDITIVE IN PLASTIC COMPOUNDING PROCESSES.

Current openFDA PMA Record#

Device
CORDIS PRECISE NITINOL STENT SYSTEMS
Applicant
Cordis US Corporation
PMA number
P030047
Supplement
S031
Product code
NIM
Generic name
Stent, carotid
Decision date
2015-05-28
Decision code
OK30
Date received
2015-05-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
USE AN ALTERNATE STABILIZING ADDITIVE IN PLASTIC COMPOUNDING PROCESSES.