Eversense Continuous Glucose Monitoring System (CGMS-Entire System), Eversense Sensor, Eversense Insertion Tools, Everse
FDA premarket approval P160048/S002 · decided 2018-11-06
Approval details
- PMA number
- P160048
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Eversense Continuous Glucose Monitoring System (CGMS-Entire System), Eversense Sensor, Eversense Insertion Tools, Everse
- Generic name
- Continuous glucose monitor, implanted, adjunctive use
- Applicant
- Senseonics, Incorporated
- Date received
- 2018-08-07
- Decision date
- 2018-11-06
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- QCD
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- Approval for modifying the instructions for use of the Eversense Continuous Glucose Monitoring System to specify that, in addition to physicians, nurse practitioners and physicians assistants who have completed the required training may insert and remove the Eversense sensor.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Eversense 365 Continuous Glucose Monitoring (CGM) System (K241335) | Senseonics, Incorporated | 2024-09-16 |
| Eversense AP CGM System (DEN230052) | Senseonics, Incorporated | 2024-04-29 |