ANIMAS VIBE SYSTEM
FDA premarket approval P130007/S013 · decided 2016-05-12
Approval details
- PMA number
- P130007
- Supplement
- S013
- 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
- 2016-04-12
- Decision date
- 2016-05-12
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- OYC
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Wayne, PA
- Statement
- Change to implement a new fixture, new set-up configuration, and a control software modification for the purpose of increasing throughput for one of the incoming inspection processes used for lot acceptance of the insulin cartridges of the Animas Vibe Insulin Pump. The Animas Vibe Insulin Pump is a component of the Animas Vibe System.
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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 |