GLUCOSE SENSOR ENLITE
FDA premarket approval P120010/S019 · decided 2014-06-18
Approval details
- PMA number
- P120010
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GLUCOSE SENSOR ENLITE
- Generic name
- Automated insulin dosing , threshold suspend
- Applicant
- Medtronic, Inc.
- Date received
- 2014-03-21
- Decision date
- 2014-06-18
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR CHANGES TO THE ENLITE GLUCOSE SENSOR (MMT-7008A, MMT-7008B) OF THE MINIMED 530G SYSTEM. SPECIFICALLY, THE SUPPLEMENT REQUESTED DESIGN MODIFICATIONS TO THE NEEDLE HUB AND NEEDLE CARRIER COMPONENTS OF THE ENLITE SENSOR TO FIT THE AUTOMATION MACHINE THAT WILL BE USED FOR THE SENSOR ASSEMBLY. ADDITIONALLY, THE NEW MANUFACTURING PROCESS WILL TAKE PLACE IN THE JUNCOS, PUERTO RICO MANUFACTURING SITE.
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