PMA P040012S026

Device
ACCULINK & RX ACCULINK CAROTID STENT SYSTEMS
Applicant
Abbott Vascular
PMA number
P040012
Supplement
S026
Product code
NIM
Decision date
2007-05-02
Generic name
Stent, carotid
Approval order statement
CHANGE TO THE STENT DEPLOYMENT FORCE LOT RELEASE TEST METHOD.

Current openFDA PMA Record#

Device
ACCULINK & RX ACCULINK CAROTID STENT SYSTEMS
Applicant
Abbott Vascular
PMA number
P040012
Supplement
S026
Product code
NIM
Generic name
Stent, carotid
Decision date
2007-05-02
Decision code
OK30
Date received
2007-04-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE TO THE STENT DEPLOYMENT FORCE LOT RELEASE TEST METHOD.