|
Device | MiniMed 630G Insulin Pump |
Generic Name | Automated insulin dosing , threshold suspend |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P150001 |
Supplement Number | S081 |
Date Received | 12/23/2019 |
Decision Date | 01/22/2020 |
Product Code |
OZO |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Modification to an existing harvest/reclaim process for construction of refurbished and loaner 630G and 670G insulin pumps. The 630G and 670G Pumps are components of the MiniMed 630G and MiniMed 670G Systems. |