Premarket Approval (PMA)

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 Sensor (3) System
• Generic Name: Sensor, glucose, invasive
• Applicant: MEDTRONIC MINIMED; 18000 DEVONSHIRE STREET; NORTHRIDGE, CA 91325-1219
• PMA Number: P160007
• Supplement Number: S005
• Date Received: 05/31/2018
• Decision Date: 06/26/2018
• 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  
Manufacturing changes for the Guardian Sensor (3): 1) adding a new ISO Class 8 Cleanroom for the manufacturing of Enlite Sensors and Guardian Sensors (3); 2) adding a new press, two new molds and a new quality control measurement system at the contract manufacturer; 3) adding an alternate injection molding machine and mold to produce the needle hub body component; 4) adding an alternative mask aligner; 5) adding a new electroplating machine; 6) adding a new sterilization site for the Enlite Sensor and the Guardian Sensor (3); 7) introducing an alternative press and mold to manufacture the sensor cap components of the Guardian Sensor (3) and implementing a new configuration number for parts manufactured. The Guardian Sensor (3) is a component of the Guardian Connect System