FDA.reportPublic FDA data

PMA P160007S027

Device
Guardian Connect System
Applicant
Medtronic Minimed
PMA number
P160007
Supplement
S027
Product code
MDS
Decision date
2019-11-04
Classification
Sensor, Glucose, Invasive
Generic name
Sensor, glucose, invasive
Approval order statement
Packaging, labeling, and final release activities of the One-Press Serter conducted at Medtronic, Inc. to be moved to contract manufacturer facility. The One-Press Serter is a component of the 530G System, the 630G System, the 670G System, and the Guardian Connect System.

Current openFDA PMA Record#

Device
Guardian Connect System
Applicant
Medtronic Minimed
PMA number
P160007
Supplement
S027
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2019-11-04
Decision code
OK30
Date received
2019-10-11
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Packaging, labeling, and final release activities of the One-Press Serter conducted at Medtronic, Inc. to be moved to contract manufacturer facility. The One-Press Serter is a component of the 530G System, the 630G System, the 670G System, and the Guardian Connect System.