MINIMED REAL-TIME TRANSMITTER (MMT-7703), CONTINUOUS GLUCOSE MONITORING SYSTEM (CGMS) IPRO DIGITAL RECORDER (MMT-7709)
FDA premarket approval P980022/S026 · decided 2008-04-23
Approval details
- PMA number
- P980022
- Supplement
- S026
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MINIMED REAL-TIME TRANSMITTER (MMT-7703), CONTINUOUS GLUCOSE MONITORING SYSTEM (CGMS) IPRO DIGITAL RECORDER (MMT-7709)
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2008-03-06
- Decision date
- 2008-04-23
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE MINIMED REAL-TIME TRANSMITTER AND THE CGMS IPRO DIGITAL RECORDER. THE MODIFICATION INCLUDES ADDING AN ESD PROTECTION DIODE AND A FEW OTHER CIRCUIT CHANGES TO THE RF INPUT/OUTPUT PORT OF THE DEVICES.
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