PMA P040012S054

Device
RX ACCULINK CAROTID STENT SYSTEM
Applicant
Abbott Vascular
PMA number
P040012
Supplement
S054
Product code
NIM
Decision date
2015-02-06
Generic name
Stent, carotid
Approval order statement
IMPLEMENT AN ALTERNATE DIGESTION SYSTEM USED TO PREPARE PURCHASED STAINLESS STEEL SAMPLES FOR CHEMICAL CHARACTERIZATION.

Current openFDA PMA Record#

Device
RX ACCULINK CAROTID STENT SYSTEM
Applicant
Abbott Vascular
PMA number
P040012
Supplement
S054
Product code
NIM
Generic name
Stent, carotid
Decision date
2015-02-06
Decision code
OK30
Date received
2015-01-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
IMPLEMENT AN ALTERNATE DIGESTION SYSTEM USED TO PREPARE PURCHASED STAINLESS STEEL SAMPLES FOR CHEMICAL CHARACTERIZATION.