MINILINK TRANSMITTER (MMT-7703) AND CGMS IPRO RECORDER (MMT-7709)
FDA premarket approval P980022/S115 · decided 2012-04-26
Approval details
- PMA number
- P980022
- Supplement
- S115
- Supplement type
- Real-Time Process
- Trade name
- MINILINK TRANSMITTER (MMT-7703) AND CGMS IPRO RECORDER (MMT-7709)
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2012-03-08
- Decision date
- 2012-04-26
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR A CHANGE FROM A SINGLE CAVITY INJECTION MOLD TO A TWO CAVITYINJECTION MOLD FOR THE MANUFACTURE OF THE CONNECTOR HOUSING AND CONTACT COMPONENTS OF THE MINILINK TRANSMITTER (MMT-7703) AND IPRO DIGITAL RECORDER (MMT-7709). THE MINILINK TRANSMITTER AND IPRO DIGITAL RECORDER ARE COMPONENTS OF PARADIGM REAL-TIME, GUARDIANREAL-TIME AND IPRO CONTINUOUS GLUCOSE MONITORING SYSTEMS.
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