|
Device | MiniMed 670G Pump |
Generic Name | Automated insulin dosing device system, single hormonal control |
Applicant | MEDTRONIC MINIMED, INC. 18000 DEVONSHIRE STREET NORTHRIDGE, CA 91325 |
PMA Number | P160017 |
Supplement Number | S030 |
Date Received | 01/23/2018 |
Decision Date | 02/22/2018 |
Product Code |
OZP |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for addition of 100% visual inspection to the manufacturing protocol for P-cap O-rings (Part Number D5022027-001) and addition of a second de-flashing procedure to remove excess flash in out-of-spec (OOS) O-rings having flash >0.003. |