Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | Guardian Connect System |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE STREET NORTHRIDGE, CA 91325-1219 |
PMA Number | P160007 |
Supplement Number | S021 |
Date Received | 05/17/2019 |
Decision Date | 06/14/2019 |
Product Code |
MDS |
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 Raising the production capacity of the Chemical Vapor Deposition (CVD) chamber to increase manufacturing capacity for the Guardian Sensor (3) continuous glucose monitoring sensor. The Guardian Sensor (3) is a component of the MiniMed 630G, Guardian Connect, and MiniMed 670G systems. |
|
|