PMA P160048S009
- Device
- Eversense Continuous Glucose Monitoring System
- Applicant
- Senseonics, Incorporated
- PMA number
- P160048
- Supplement
- S009
- Product code
- QCD
- Decision date
- 2019-06-26
- Classification
- Continuous Glucose Monitor, Implanted, Adjunctive Use
- Generic name
- Continuous glucose monitor, implanted, adjunctive use
- Approval order statement
- Increased load size for a previously approved sterilization method, as well as approval for a new sealing device for the sterile barrier of the sensor component of the Eversense CGM system.
Current openFDA PMA Record#
- Device
- Eversense Continuous Glucose Monitoring System
- Applicant
- Senseonics, Incorporated
- PMA number
- P160048
- Supplement
- S009
- Product code
- QCD
- Generic name
- Continuous glucose monitor, implanted, adjunctive use
- Decision date
- 2019-06-26
- Decision code
- OK30
- Date received
- 2019-05-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Increased load size for a previously approved sterilization method, as well as approval for a new sealing device for the sterile barrier of the sensor component of the Eversense CGM system.