OneTouch Vibe Plus System
FDA premarket approval P130007/S016 · decided 2016-12-16
Approval details
- PMA number
- P130007
- Supplement
- S016
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OneTouch Vibe Plus System
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Applicant
- Animas Corp.
- Date received
- 2016-06-06
- Decision date
- 2016-12-16
- Days to decision
- 193 days
- Decision code
- APPR
- Product code
- OYC
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Wayne, PA
- Statement
- Approval for the OneTouch Vibe Plus System is indicated for continuous subcutaneous insulin infusion for the management of insulin-requiring diabetes. It can be used solely for continuous insulin delivery and as part of the OneTouch Vibe Plus System to receive and display continuous glucose measurements from the Dexcom G5® Sensor and Transmitter. The OneTouch Vibe Plus System's continuous glucose monitoring (CGM) is indicated for detecting trends and tracking patterns in persons (ages 2 and olde
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SYMPHONY GLUCOSE MANAGEMENT SYSTEM (K080639) | Animas Corp. | 2008-06-24 |
| EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE (K080587) | Animas Corp. | 2008-05-15 |
| EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE (K063674) | Animas Corp. | 2007-03-30 |
| ANIMAS MODEL IR1250 INSULIN INFUSION PUMP (K042873) | Animas Corp. | 2004-12-10 |
| MODEL IR 1200 INSULIN PUMP (K032257) | Animas Corp. | 2003-10-16 |
| EZMANAGER PLUS (K022394) | Animas Corp. | 2003-06-05 |
| ANIMUS EZSERTER INFUSION SET INSERTER (K021700) | Animas Corp. | 2002-06-04 |
| MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO (K021439) | Animas Corp. | 2002-05-29 |