Eversense Continuous Glucose Monitoring System
FDA premarket approval P160048/S007 · decided 2019-01-15
Approval details
- PMA number
- P160048
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Eversense Continuous Glucose Monitoring System
- Generic name
- Continuous glucose monitor, implanted, adjunctive use
- Applicant
- Senseonics, Incorporated
- Date received
- 2018-11-28
- Decision date
- 2019-01-15
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- QCD
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- Approval for modification to the approved post-approval study protocol to include nurse practitioners and physicians assistants, in addition to physicians, as practitioners who will perform sensor insertions and removals.
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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 |