FDA.reportPublic FDA data

PMA P160007S042

Device
Guardian™ Connect system
Applicant
Medtronic Minimed
PMA number
P160007
Supplement
S042
Product code
MDS
Decision date
2021-12-17
Generic name
Sensor, glucose, invasive
Approval order statement
Approval for 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
Guardian™ Connect system
Applicant
Medtronic Minimed
PMA number
P160007
Supplement
S042
Product code
MDS
Generic name
Sensor, glucose, invasive
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 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.