FDA.reportPublic FDA data

PMA P160017S095

Device
MiniMed™ 670G System
Applicant
Medtronic Minimed, Inc.
PMA number
P160017
Supplement
S095
Product code
OZP
Decision date
2021-12-17
Generic name
Automated insulin dosing device system, single hormonal control
Approval order statement
Approval for approval for a labeling update to provide additional clarity on an existing warning for acetaminophen interference to the continuous glucose monitoring (CGM) component of the system.

Current openFDA PMA Record#

Device
MiniMed™ 670G System
Applicant
Medtronic Minimed, Inc.
PMA number
P160017
Supplement
S095
Product code
OZP
Generic name
Automated insulin dosing device system, single hormonal control
Decision date
2021-12-17
Decision code
APPR
Date received
2021-11-17
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for approval for a labeling update to provide additional clarity on an existing warning for acetaminophen interference to the continuous glucose monitoring (CGM) component of the system.