PMA P110001S005

Device
HERCULINK ELITE, RX
Applicant
Abbott Vascular
PMA number
P110001
Supplement
S005
Product code
NIN
Decision date
2012-06-21
Generic name
STENT, RENAL
Approval order statement
REDUCE THE NUMBER OF SAMPLES USED FROM EACH LOT DURING PYROGEN TESTING.

Current openFDA PMA Record#

Device
HERCULINK ELITE, RX
Applicant
Abbott Vascular
PMA number
P110001
Supplement
S005
Product code
NIN
Generic name
STENT, RENAL
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.