PMA P040012S020

Device
RX ACCULINK & ACCULINK CAROTID STENT SYSTEMS
Applicant
Abbott Vascular
PMA number
P040012
Supplement
S020
Product code
NIM
Decision date
2007-01-05
Generic name
Stent, carotid
Approval order statement
APPROVAL FOR A CHANGE IN THE CLEANING METHODS TO REMOVE MANUFACTURING MATERIALS IN RX ACCULINK AND ACCULINK CAROTID STENTS.

Current openFDA PMA Record#

Device
RX ACCULINK & ACCULINK CAROTID STENT SYSTEMS
Applicant
Abbott Vascular
PMA number
P040012
Supplement
S020
Product code
NIM
Generic name
Stent, carotid
Decision date
2007-01-05
Decision code
APPR
Date received
2006-07-14
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A CHANGE IN THE CLEANING METHODS TO REMOVE MANUFACTURING MATERIALS IN RX ACCULINK AND ACCULINK CAROTID STENTS.