ANIMAS VIBE SYSTEM
FDA premarket approval P130007/S004 · decided 2015-12-24
Approval details
- PMA number
- P130007
- Supplement
- S004
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ANIMAS VIBE SYSTEM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Animas Corp.
- Date received
- 2015-04-30
- Decision date
- 2015-12-24
- Days to decision
- 238 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Wayne, PA
- Statement
- APPROVAL FOR THE ANIMAS VIBE SYSTEM. THE ANIMAS® VIBE SYSTEM CONSISTS OF THE ANIMAS VIBE INSULIN PUMP PAIRED WITH THE DEXCOM G4 PLATINUM CGM SENSOR AND TRANSMITTER.THE ANIMAS VIBE INSULIN PUMP IS INTENDED FOR THE CONTINUOUS SUBCUTANEOUS INFUSION OF INSULIN FOR THE MANAGEMENT OF INSULIN-REQUIRING DIABETES. IT CAN BE USED SOLELY FOR CONTINUOUS INSULIN DELIVERY OR AS PART OF THE ANIMAS VIBE SYSTEM TO RECEIVE AND DISPLAY CONTINUOUS GLUCOSE MEASUREMENTS FROM THE DEXCOM G4 PLATINUM SENSOR AND TRANSMIT
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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 |