PMA P040012S029

Device
ACCULINK/RX ACCULINK CAROTID STENT SYSTEMS
Applicant
Abbott Vascular
PMA number
P040012
Supplement
S029
Product code
NIM
Decision date
2009-01-21
Generic name
Stent, carotid
Approval order statement
CHANGE FROM A MANUAL TO AN AUTOMATED PROCESS FOR MEASURING A COMPONENT SPECIFICATION.

Current openFDA PMA Record#

Device
ACCULINK/RX ACCULINK CAROTID STENT SYSTEMS
Applicant
Abbott Vascular
PMA number
P040012
Supplement
S029
Product code
NIM
Generic name
Stent, carotid
Decision date
2009-01-21
Decision code
OK30
Date received
2008-12-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE FROM A MANUAL TO AN AUTOMATED PROCESS FOR MEASURING A COMPONENT SPECIFICATION.