PMA P030047S033

Device
PRECISE NITINOL STENT SYSTEM
Applicant
Cordis US Corporation
PMA number
P030047
Supplement
S033
Product code
NIM
Decision date
2016-12-08
Classification
Stent, Carotid
Generic name
Stent, carotid
Approval order statement
Introduction of new stent laser cutting equipment.

Current openFDA PMA Record#

Device
PRECISE NITINOL STENT SYSTEM
Applicant
Cordis US Corporation
PMA number
P030047
Supplement
S033
Product code
NIM
Generic name
Stent, carotid
Decision date
2016-12-08
Decision code
OK30
Date received
2016-11-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Introduction of new stent laser cutting equipment.