FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Sensor, Glucose, Invasive
PMA: P160007
·
Supplement: S062
·
Decision May 26, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Sensor, Glucose, Invasive
- Trade Name
- Simplera and Simplera Sync
- PMA Number
- P160007
- Supplement Number
- S062
- Device Class
- FDA Class 3
- Product Code
- MDS
- Generic Name
- Sensor, glucose, invasive
- Medical Specialty
- Unknown
- Advisory Committee
- Clinical Chemistry
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- May 26, 2026
- Date Received
- April 27, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
to increase the capacity for the degassing of Simplera and Simplera Sync sensors by adding an additional degassing aeration room (Degassing Room #3) at a sterilization facility. The Simplera sensor is a component of the Simplera system. The Simplera Sync sensor is a component of the MiniMed 780G system. The Simplera Sync sensor is also approved for use with compatible cleared MiniMed devices
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MDS | Sensor, Glucose, Invasive | FDA class 3 | Unknown |