PMA P160017S110

Device
MiniMed 780G System
Applicant
Medtronic Minimed, Inc.
PMA number
P160017
Supplement
S110
Product code
OZP
Decision date
2023-06-15
Classification
Clinical Chemistry
Generic name
Automated insulin dosing device system, single hormonal control
Approval order statement
Approval of the protocol for the post-approval study (PAS)

Current openFDA PMA Record#

Device
MiniMed 780G System
Applicant
Medtronic Minimed, Inc.
PMA number
P160017
Supplement
S110
Product code
OZP
Generic name
Automated insulin dosing device system, single hormonal control
Decision date
2023-06-15
Decision code
APPR
Date received
2023-05-17
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
Approval of the protocol for the post-approval study (PAS)