PMA P020047S074

Device
MULTI-LINK VISION, MULTI-LINK MINI VISION and MULTI-LINK 8 Coronary Stent Systems
Applicant
Abbott Vascular
PMA number
P020047
Supplement
S074
Product code
MAF
Decision date
2021-03-24
Generic name
STENT, CORONARY
Approval order statement
Change to the sub-assembly stent inspection process to increase manufacturing efficiency.

Current openFDA PMA Record#

Device
MULTI-LINK VISION, MULTI-LINK MINI VISION and MULTI-LINK 8 Coronary Stent Systems
Applicant
Abbott Vascular
PMA number
P020047
Supplement
S074
Product code
MAF
Generic name
STENT, CORONARY
Decision date
2021-03-24
Decision code
OK30
Date received
2021-02-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change to the sub-assembly stent inspection process to increase manufacturing efficiency.