EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA premarket approval P160048/S029 · decided 2025-03-27
Approval details
- PMA number
- P160048
- Supplement
- S029
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
- Generic name
- Sensor, glucose, implanted, non-adjunctive use
- Applicant
- Senseonics, Incorporated
- Date received
- 2025-02-25
- Decision date
- 2025-03-27
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- QHJ
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
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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 |