PMA P150001S092
- Device
- MiniMed 630G System with SmartGuard Technology
- Applicant
- Medtronic Minimed
- PMA number
- P150001
- Supplement
- S092
- Product code
- OZO
- Decision date
- 2021-10-05
- Generic name
- Automated insulin dosing , threshold suspend
- 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 630G System with SmartGuard Technology
- Applicant
- Medtronic Minimed
- PMA number
- P150001
- Supplement
- S092
- Product code
- OZO
- Generic name
- Automated insulin dosing , threshold suspend
- 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.