PMA P160017S094
- Device
- MiniMed 670G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S094
- Product code
- OZP
- Decision date
- 2021-10-05
- Generic name
- Automated insulin dosing device system, single hormonal control
- Approval order statement
- Addition of equivalent e-beam sterilization equipment at an approved site of a current contract sterilizer.
Current openFDA PMA Record#
- Device
- MiniMed 670G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S094
- Product code
- OZP
- Generic name
- Automated insulin dosing device system, single hormonal control
- Decision date
- 2021-10-05
- Decision code
- OK30
- Date received
- 2021-09-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of equivalent e-beam sterilization equipment at an approved site of a current contract sterilizer.