PMA P040012S036

Device
ACCULINK CAROTID STENT SYSTEM
Applicant
Abbott Vascular
PMA number
P040012
Supplement
S036
Product code
NIM
Decision date
2011-07-28
Generic name
Stent, carotid
Approval order statement
APPROVAL FOR CHANGES TO YOUR SOLUTION MANUFACTURING PROCESS.

Current openFDA PMA Record#

Device
ACCULINK CAROTID STENT SYSTEM
Applicant
Abbott Vascular
PMA number
P040012
Supplement
S036
Product code
NIM
Generic name
Stent, carotid
Decision date
2011-07-28
Decision code
APPR
Date received
2011-02-18
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR CHANGES TO YOUR SOLUTION MANUFACTURING PROCESS.