PMA P160017S122

Device: MiniMed 770G System
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S122
Product code: OZP
Decision date: 2025-08-20
Classification: Clinical Chemistry
Generic name: Automated insulin dosing device system, single hormonal control
Approval order statement: Approval for modified labeling for the MiniMed 770G System to include descriptive results of the post-approval study previously mandated under the approval order of P160017.

Current openFDA PMA Record#

Device: MiniMed 770G System
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S122
Product code: OZP
Generic name: Automated insulin dosing device system, single hormonal control
Decision date: 2025-08-20
Decision code: APPR
Date received: 2025-02-21
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval for modified labeling for the MiniMed 770G System to include descriptive results of the post-approval study previously mandated under the approval order of P160017.