Animas Vibe System
FDA premarket approval P130007/S031 · decided 2017-10-24
Approval details
- PMA number
- P130007
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Animas Vibe System
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Applicant
- Animas Corp.
- Date received
- 2017-09-29
- Decision date
- 2017-10-24
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- OYC
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Wayne, PA
- Statement
- Supplier change for the manufacturing of a molded component of the key pad assembled into the Animas Vibe Insulin pump which is part of the Animas Vibe System. The Animas Vibe System consists of the Animas Vibe Insulin Pump paired with the Dexcom G4 PLATINUM Sensor and Transmitter.
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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 |