PMA P040012S013

Device
RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS
Applicant
Abbott Vascular
PMA number
P040012
Supplement
S013
Product code
NIM
Decision date
2006-03-24
Generic name
Stent, carotid
Approval order statement
CHANGE IN THE PROCEDURE FOR VERIFYING STENT OUTER DIAMETER DURING STENT CLEANING PROCESS.

Current openFDA PMA Record#

Device
RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS
Applicant
Abbott Vascular
PMA number
P040012
Supplement
S013
Product code
NIM
Generic name
Stent, carotid
Decision date
2006-03-24
Decision code
OK30
Date received
2006-02-28
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE IN THE PROCEDURE FOR VERIFYING STENT OUTER DIAMETER DURING STENT CLEANING PROCESS.