PMA P040012S051

Device
ACCULINK CAROTID STENT SYSTEM
Applicant
Abbott Vascular
PMA number
P040012
Supplement
S051
Product code
NIM
Decision date
2013-01-24
Generic name
Stent, carotid
Approval order statement
MANUFACTURING TRANSFER FOR THE DELIVERY SYSTEMS OF THE DEVICES WITHIN THE SAME SITE.

Current openFDA PMA Record#

Device
ACCULINK CAROTID STENT SYSTEM
Applicant
Abbott Vascular
PMA number
P040012
Supplement
S051
Product code
NIM
Generic name
Stent, carotid
Decision date
2013-01-24
Decision code
OK30
Date received
2012-12-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
MANUFACTURING TRANSFER FOR THE DELIVERY SYSTEMS OF THE DEVICES WITHIN THE SAME SITE.