Sensor, Glucose, Invasive
Basic Information
- Device Name
- Sensor, Glucose, Invasive
- Trade Name
- Guardian Sensor (3) System
- PMA Number
- P160007
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- MDS
- Generic Name
- Sensor, glucose, invasive
- Medical Specialty
- Unknown
- Advisory Committee
- Clinical Chemistry
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- June 26, 2018
- Date Received
- May 31, 2018
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee 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
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MDS | Sensor, Glucose, Invasive | FDA class 3 | Unknown |