FDA.reportPublic FDA data

PMA P150001S107

Device
MiniMed 630G system
Applicant
Medtronic Minimed
PMA number
P150001
Supplement
S107
Product code
OZO
Decision date
2023-10-30
Classification
Clinical Chemistry
Generic name
Automated insulin dosing , threshold suspend
Approval order statement
Approval for a minor design change to the battery cap assembly component of the 630G, 670G, 770G, and 780G pumps. The 630G, 670G, 770G, and 780G pumps are a part of the MiniMed 630G system, MiniMed 670G system, MiniMed 770G system and MiniMed 780G system, respectively.

Current openFDA PMA Record#

Device
MiniMed 630G system
Applicant
Medtronic Minimed
PMA number
P150001
Supplement
S107
Product code
OZO
Generic name
Automated insulin dosing , threshold suspend
Decision date
2023-10-30
Decision code
APPR
Date received
2023-08-15
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a minor design change to the battery cap assembly component of the 630G, 670G, 770G, and 780G pumps. The 630G, 670G, 770G, and 780G pumps are a part of the MiniMed 630G system, MiniMed 670G system, MiniMed 770G system and MiniMed 780G system, respectively.