PMA P040012S041

Device
RX ACCULINK SELF-EXPANDING STENT SYSTEM
Applicant
Abbott Vascular
PMA number
P040012
Supplement
S041
Product code
NIM
Decision date
2011-09-01
Generic name
Stent, carotid
Approval order statement
IMPLEMENTATION OF AN AUTOMATED SYSTEM FOR PROCESS MONITORING.

Current openFDA PMA Record#

Device
RX ACCULINK SELF-EXPANDING STENT SYSTEM
Applicant
Abbott Vascular
PMA number
P040012
Supplement
S041
Product code
NIM
Generic name
Stent, carotid
Decision date
2011-09-01
Decision code
OK30
Date received
2011-08-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
IMPLEMENTATION OF AN AUTOMATED SYSTEM FOR PROCESS MONITORING.