PMA P020047S060

Device
MULTI-LINK 8 CORONARY STENT SYSTEM
Applicant
Abbott Vascular
PMA number
P020047
Supplement
S060
Product code
MAF
Decision date
2014-10-24
Classification
Stent, Coronary
Generic name
STENT, CORONARY
Approval order statement
CHANGE TO THE PYROGEN TESTING PROCESS.

Current openFDA PMA Record#

Device
MULTI-LINK 8 CORONARY STENT SYSTEM
Applicant
Abbott Vascular
PMA number
P020047
Supplement
S060
Product code
MAF
Generic name
STENT, CORONARY
Decision date
2014-10-24
Decision code
OK30
Date received
2014-09-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE TO THE PYROGEN TESTING PROCESS.