PMA P030047S024

Device
PRECISE, PRECISE RX, AND PRECISE PRO RXNITINOL STENT SYSTEMS
Applicant
Cordis US Corporation
PMA number
P030047
Supplement
S024
Product code
NIM
Decision date
2012-03-22
Classification
Stent, Carotid
Generic name
Stent, carotid
Approval order statement
PACKAGE HANDLING CHANGE TO THE HEAT SEALING PROCESS.

Current openFDA PMA Record#

Device
PRECISE, PRECISE RX, AND PRECISE PRO RXNITINOL STENT SYSTEMS
Applicant
Cordis US Corporation
PMA number
P030047
Supplement
S024
Product code
NIM
Generic name
Stent, carotid
Decision date
2012-03-22
Decision code
OK30
Date received
2012-02-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
PACKAGE HANDLING CHANGE TO THE HEAT SEALING PROCESS.