FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Sensor, Glucose, Invasive, Non-Adjunctive
PMA: P160007
·
Supplement: S052
·
Decision Sep 17, 2024
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Sensor, Glucose, Invasive, Non-Adjunctive
- Trade Name
- Simplera (TM) System
- PMA Number
- P160007
- Supplement Number
- S052
- Device Class
- FDA Class 3
- Product Code
- PQF
- Generic Name
- Sensor, glucose, invasive, non-adjunctive
- Medical Specialty
- Unknown
- Advisory Committee
- Clinical Chemistry
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- September 17, 2024
- Date Received
- August 21, 2024
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
addition of two new sterilization chambers for sterilization of Simplera sensors. The Simplera sensor is a component of the Simplera System
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 |
|---|---|---|---|
| PQF | Sensor, Glucose, Invasive, Non-Adjunctive | FDA class 3 | Unknown |