FDA.reportPublic FDA data

PMA P120010S140

Device
MiniMed™ 530G System
Applicant
Medtronic, Inc.
PMA number
P120010
Supplement
S140
Product code
OZO
Decision date
2021-12-17
Generic name
Automated insulin dosing , threshold suspend
Approval order statement
Approval for a labeling update to provide additional clarity on an existing warning for acetaminophen interference to the continuous glucose monitoring (CGM) component of the system.

Current openFDA PMA Record#

Device
MiniMed™ 530G System
Applicant
Medtronic, Inc.
PMA number
P120010
Supplement
S140
Product code
OZO
Generic name
Automated insulin dosing , threshold suspend
Decision date
2021-12-17
Decision code
APPR
Date received
2021-11-17
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for a labeling update to provide additional clarity on an existing warning for acetaminophen interference to the continuous glucose monitoring (CGM) component of the system.