PMA P970020

Device
MULTI-LINK RX ULTRA™ Coronary Stent System
Applicant
Abbott Vascular, Inc.
PMA number
P970020
Supplement
S086
Product code
MAF
Decision date
2022-09-07
Generic name
STENT, CORONARY
Approval order statement
Addition of secondary sterilization equipment.

Current openFDA PMA Record#

Device
MULTI-LINK RX ULTRA™ Coronary Stent System
Applicant
Abbott Vascular, Inc.
PMA number
P970020
Supplement
S086
Product code
MAF
Generic name
STENT, CORONARY
Decision date
2022-09-07
Decision code
OK30
Date received
2022-08-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of secondary sterilization equipment.