PMA P020047S077

Device
MULTI-LINK VISION RX Coronary Stent System, MULTI-LINK MINI VISION Coronary Stent System
Applicant
Abbott Vascular
PMA number
P020047
Supplement
S077
Product code
MAF
Decision date
2023-06-12
Classification
Cardiovascular
Generic name
STENT, CORONARY
Approval order statement
Implementing a new test method and test location for the resin proximal shaft raw material.

Current openFDA PMA Record#

Device
MULTI-LINK VISION RX Coronary Stent System, MULTI-LINK MINI VISION Coronary Stent System
Applicant
Abbott Vascular
PMA number
P020047
Supplement
S077
Product code
MAF
Generic name
STENT, CORONARY
Decision date
2023-06-12
Decision code
OK30
Date received
2023-05-15
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementing a new test method and test location for the resin proximal shaft raw material.