FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
PMA: P130007
·
Supplement: S035
·
Decision Apr 18, 2018
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
- Trade Name
- Animas Vibe System
- PMA Number
- P130007
- Supplement Number
- S035
- 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
- April 18, 2018
- Date Received
- March 20, 2018
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Manufacturing site change of the contract manufacturer for the Animas 2.0mL cartridge, which is part of the Animas Vibe 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 |