FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Automated Insulin Dosing Device System, Single Hormonal Control
PMA: P160017
·
Supplement: S136
·
Decision Mar 19, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Automated Insulin Dosing Device System, Single Hormonal Control
- Trade Name
- Simplera Sync Sensor
- PMA Number
- P160017
- Supplement Number
- S136
- Device Class
- FDA Class 3
- Product Code
- OZP
- Generic Name
- Automated insulin dosing device system, single hormonal control
- Medical Specialty
- Unknown
- Advisory Committee
- Clinical Chemistry
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- March 19, 2026
- Date Received
- February 20, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
to add the Medtronic Northridge facility as an additional site for conducting post-sterilization quality testing for the Simplera Sync sensor. The Simplera Sync sensor is a component of the MiniMed 780G 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 |
|---|---|---|---|
| OZP | Automated Insulin Dosing Device System, Single Hormonal Control | FDA class 3 | Unknown |