EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA premarket approval P160048/S012 · decided 2019-11-25
Approval details
- PMA number
- P160048
- Supplement
- S012
- 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
- 2019-07-03
- Decision date
- 2019-11-25
- Days to decision
- 145 days
- Decision code
- APPR
- Product code
- QHJ
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- Approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P160048/S006
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 |