Eversense Continuous Glucose Monitoring System
FDA premarket approval P160048/S014 · decided 2019-10-29
Approval details
- PMA number
- P160048
- Supplement
- S014
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Eversense Continuous Glucose Monitoring System
- Generic name
- Sensor, glucose, implanted, non-adjunctive use
- Applicant
- Senseonics, Incorporated
- Date received
- 2019-08-27
- Decision date
- 2019-10-29
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- QHJ
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- Approval for a manufacturing site located at Steris Isomedix Services, 3459 South Clinton Ave., South Plainfield, NJ 07080 for use as a sterilization site for the sensor insertion tools of the Eversense Continuous Glucose Monitoring System.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |