PMA P970020S085

Device
Multi-Link RX Ultra Coronary Stent System
Applicant
Abbott Vascular, Inc.
PMA number
P970020
Supplement
S085
Product code
MAF
Decision date
2021-06-21
Generic name
STENT, CORONARY
Approval order statement
New resin colorant supplier for delivery system components.

Current openFDA PMA Record#

Device
Multi-Link RX Ultra Coronary Stent System
Applicant
Abbott Vascular, Inc.
PMA number
P970020
Supplement
S085
Product code
MAF
Generic name
STENT, CORONARY
Decision date
2021-06-21
Decision code
OK30
Date received
2021-04-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New resin colorant supplier for delivery system components.