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PMA P160007S034

Device
Guardian Connect System
Applicant
Medtronic Minimed
PMA number
P160007
Supplement
S034
Product code
MDS
Decision date
2020-01-31
Generic name
Sensor, glucose, invasive
Approval order statement
New sterilization site for the sterilization of the Guardian Sensor (3) continuous glucose monitoring sensors that are manufactured at Medtronic Puerto Rico Operations Company. The Guardian Sensor (3) is a component of the MiniMed 630G system, the Guardian Connect system, and the MiniMed 670G system.

Current openFDA PMA Record#

Device
Guardian Connect System
Applicant
Medtronic Minimed
PMA number
P160007
Supplement
S034
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2020-01-31
Decision code
OK30
Date received
2020-01-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New sterilization site for the sterilization of the Guardian Sensor (3) continuous glucose monitoring sensors that are manufactured at Medtronic Puerto Rico Operations Company. The Guardian Sensor (3) is a component of the MiniMed 630G system, the Guardian Connect system, and the MiniMed 670G system.