PMA P030047S021

Device
PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENTS SYSTEMS
Applicant
Cordis US Corporation
PMA number
P030047
Supplement
S021
Product code
NIM
Decision date
2010-08-27
Classification
Stent, Carotid
Generic name
Stent, carotid
Approval order statement
ADDITION OF AN IN-PROCESS INSPECTION.

Current openFDA PMA Record#

Device
PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENTS SYSTEMS
Applicant
Cordis US Corporation
PMA number
P030047
Supplement
S021
Product code
NIM
Generic name
Stent, carotid
Decision date
2010-08-27
Decision code
OK30
Date received
2010-07-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF AN IN-PROCESS INSPECTION.