FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
PMA: P140015
·
Supplement: S029
·
Decision Dec 19, 2019
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
- Trade Name
- t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System
- PMA Number
- P140015
- Supplement Number
- S029
- Device Class
- FDA Class 3
- Product Code
- OYC
- Generic Name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Medical Specialty
- Unknown
- Advisory Committee
- Clinical Chemistry
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 19, 2019
- Date Received
- November 20, 2019
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Rework process change related to the assembling of the Printed Circuit Board Assembly (PCBA) at a Tandem supplier. The PCBA is a component of the Tandem t:slim X2 Insulin Pump 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 |
|---|---|---|---|
| OYC | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | FDA class 3 | Unknown |