ANIMAS VIBE SYSTEM
FDA premarket approval P130007/S002 · decided 2015-06-22
Approval details
- PMA number
- P130007
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ANIMAS VIBE SYSTEM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Animas Corp.
- Date received
- 2015-03-26
- Decision date
- 2015-06-22
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Wayne, PA
- Statement
- APPROVAL FOR SUBSTITUTION OF 4 COMPONENTS (MEMORY, TRANSISTOR, MICRO-PROCESSING UNIT, CONNECTOR) ON THE PRINTED CIRCUIT BOARD (PCB) OF THE APPROVED ANIMAS VIBE INSULIN PUMP. ONE OF THE REPLACEMENT COMPONENTS (MICRO-PROCESSING UNIT) REQUIRES A MODIFICATION TO THE PCB LAYOUT.
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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 |