FDA.reportPublic FDA data

PMA P160007S040

Device
Guardian Connect system
Applicant
Medtronic Minimed
PMA number
P160007
Supplement
S040
Product code
MDS
Decision date
2021-02-25
Generic name
Sensor, glucose, invasive
Approval order statement
Approval for an update to product labeling to warn against a new interference by Hydroxyurea 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
S040
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2021-02-25
Decision code
APPR
Date received
2021-01-27
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for an update to product labeling to warn against a new interference by Hydroxyurea to the continuous glucose monitoring (CGM) component of the system.