PMA P040012S045

Device
ACCULINK, RX
Applicant
Abbott Vascular
PMA number
P040012
Supplement
S045
Product code
NIM
Decision date
2012-06-21
Generic name
Stent, carotid
Approval order statement
REDUCE THE NUMBER OF SAMPLES USED FROM EACH LOT DURING PYROGEN TESTING.

Current openFDA PMA Record#

Device
ACCULINK, RX
Applicant
Abbott Vascular
PMA number
P040012
Supplement
S045
Product code
NIM
Generic name
Stent, carotid
Decision date
2012-06-21
Decision code
OK30
Date received
2012-05-24
Supplement type
30-Day Notice
Approval order statement
REDUCE THE NUMBER OF SAMPLES USED FROM EACH LOT DURING PYROGEN TESTING.